[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-coronary-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-coronary-syndrome":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,103,0,25,[9,45,90,119,148,191,225,251,274,302,325,361,391,415,444,473,498,527,559,587,611,638,657,685,705],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100651552","early-phase-1-echocardiographic-molecular-imaging-for-poc-detection-of-ischemia-100651552",false,"NCT07762495","Echocardiographic Molecular Imaging for POC Detection of Ischemia","Inclusion Criteria:\n\n* Age ≥18 years of age\n* Patients with possible or suspected ACS based on clinical criteria (history, ECG, laboratories) and HEART score \\>3.\n\nExclusion Criteria:\n\n* Cardiogenic shock\n* Inability to obtain consent\n* Severe heart failure (NYHA class IV)\n* Mechanical complication of MI (ischemic VSD, papillary muscle rupture, ventricular free wall rupture)\n* Ongoing life-threatening arrhythmias\n* Neutropenia (\\\u003C1,500\u002Fmm3)\n* Pregnancy\n* Lactation\n* Allergy to ultrasound contrast agents or eggs\n* History of autoimmune or inflammatory disease with myocardial involvement (SLE, sarcoidosis, giant cell myocarditis, etc.)","ALL","18 Years","99 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","Molecular imaging with myocardial contrast echocardiography (MCE) relies on the non-invasive detection of targeted microbubbles (MBs) or other acoustically active agents. The confinement of MBs to the vascular compartment makes them ideal for assessing acute inflammatory responses involving endothelial cell activation and immune cell recruitment. A construct for imaging inflammation and endothelial activation can be achieved by altering amphipathic lipid shell composition in MBs. Specifically, incorporation of phosphatidylserine (PS) into the shell of MBs promotes adhesion to activated leukocytes and endothelial cells which can be used to detect ischemia, whether active or resolved. Our first in human studies to use myocardial contrast echocardiography (MCE) to detect inflammation secondary to ischemia was performed with a PS-containing MB contrast agent (Sonazoid) where we studied patients with known acute coronary syndrome (ACS) who had just undergone acute percutaneous coronary intervention. In this study, we will conduct a proof-of-concept clinical trial where MCE molecular imaging with Sonazoid will be performed in 80 patients with suspected rather than known ACS. We will test whether MCE ischemic memory imaging with MB-PS can diagnose or exclude ACS, and assess risk based on spatial extent of signal enhancement.",[27],"Acute Coronary Syndrome",[29,30,31,32],"acute coronary syndrome","echocardiography","Microbubbles","Myocardial contrast echocardiography","NOT_YET_RECRUITING","2026-08-17",{"date":36,"type":37},"2026-08-20","ACTUAL",{"date":39,"type":21},"2026-09-30",{"date":41,"type":21},"2030-07-30",{"name":43,"class":44},"University of Virginia","OTHER",{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"100559630","cardiac-mri-prior-to-invasive-coronary-angiography-in-patients-with-suspected-non-st-elevation-myocardial-infarction-100559630","NCT06566625","Cardiac MRI Prior to Invasive Coronary Angiography in Patients With Suspected Non-ST-Elevation Myocardial Infarction","The Karolinska Pilot Study for Cardiac Magnetic Resonance Imaging Prior to Invasive Coronary Angiography in Patients With Suspected Non-ST-Elevation Myocardial Infarction","KaPSICA-CMR","Inclusion Criteria:\n\n* ≥18 years of age Suspected NSTEMI (signs and symptoms suggest of ACS with initial ECG showing no ST-elevation)\n* Planned ICA where CMR can be performed without delaying ICA\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Contraindications for CMR examination with gadolinium contrast (claustrophobia, eGFR \\\u003C30ml\u002Fmin\u002F1.73m2, contrast allergy, and non-MRI compatible implants)\n* Arrythmias which hinder CMR examination\n* Previous CABG\n* Hemodynamic instability\n* Myocardial infarction \\\u003C6 months prior to inclusion",{"count":54,"type":21},150,"OBSERVATIONAL","Patients with a suspected myocardial infarction are subdivided into ST-elevation and non-ST-elevation myocardial infarctions (STEMI and NSTEMI, respectively) using ECG. While patients with STEMI are urgently referred to a cath lab, patients with NSTEMI usually undergo a planned invasive coronary angiography (ICA) anywhere from 24-72 hours after arriving to the hospital. When an invasive coronary angiography can not explain the cause of a myocardial infarction, an MRI of the heart (a CMR) is often done as a follow-up investigation.\n\nA growing body of evidence suggests that performing a CMR before the planned ICA can provide an accurate diagnosis and defer the need for an ICA in many of these patients with NSTEMI.",[58,27],"Non-ST Elevation Myocardial Infarction",[60,61,62,63,64,65,66,27,67,68,69,70,71,72,73,74,75,76,77],"CMR","MRI","Cardiac MRI","Cardiac Magnetic Resonance","Cardiac Magnetic Resonance imaging","AMI","ACS","NSTEMI","Non-STEMI","ICA","Invasive Coronary Angiography","Coronary Angiography","T1","T2","Magnetic Resonance Fingerprinting","Native T1","Native T2","Magnetic Resonance Angiography","RECRUITING","2026-08-10",{"date":81,"type":37},"2026-08-12",{"date":83,"type":37},"2024-07-17",{"date":85,"type":21},"2027-05",{"name":87,"class":88},"Region Stockholm","OTHER_GOV",1,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":89},"100488342","phase-4-noac-therapy-guided-by-paris-risk-score-and-d-dimer-in-patients-with-acs-after-pci-100488342","NCT05638867","NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI","A Randomized Controlled Clinical Trial of PARIS Coronary Thrombosis Risk Score Combined With D-dimer to Guide New Oral Anticoagulant Antithrombotic Therapy in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention","Inclusion Criteria:\n\n* Diagnosed with Acute Coronary Syndrome 1-7 days after initial symptom stabilization,\n* Aged 18-75 years old,\n* Elevated D-dimer levels (≥0.28 μg\u002Fml) on admission or PARIS coronary thrombosis risk score ≥ 3 points,\n* Received Percutaneous Coronary Intervention and not on non-oral anticoagulants,\n* Indicated for dual antiplatelet medication\n\nExclusion Criteria:\n\n* Platelet level below 90 x10\\^6\n* Hemoglobin level is less than 11g\u002FdL\n* History of severe bleeding\n* History of stroke\u002FTIA\n* Severe hepatic\u002Frenal insufficiency\n* Indicated for anticoagulation","75 Years",{"count":99,"type":21},3944,[101],"PHASE4","The goal of this clinical trial is to compare short-term Triple Antithrombotic Therapy (DAPT + Rivaroxaban) followed by DAPT with standard DAPT in selected ACS patients with high ischemic risk. The main questions it aims to answer are:\n\n* Whether the intervention is effective in reducing ischemic events\n* Whether the intervention is safe from increasing bleeding events, especially severe or fatal ones\n\nParticipants will be randomized to receive standard DAPT therapy for the entire study duration or low-dose rivaroxaban+DAPT for 3 months, followed by standard DAPT for the rest of the study duration. Patients enrolled should complete 5 follow-ups in the form of clinic visit or telephone call.",[104,105,27],"Coronary Artery Disease","Percutaneous Coronary Intervention",[107,108,109,27,105],"Novel Oral Anticoagulant","PARIS risk score","D-dimer","2026-08-09",{"date":112,"type":37},"2026-08-11",{"date":114,"type":37},"2023-11-25",{"date":116,"type":21},"2027-01",{"name":118,"class":88},"China National Center for Cardiovascular Diseases",{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":66,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":130,"conditions":131,"keywords":132,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":147},"100600833","phase-3-evaluation-of-efficacy-and-safety-of-early-in-hospital-initiation-of-inclisiran-treatment-in-patients-with-acute-coronary-syndromes-100600833","NCT07102628","Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes","A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes: Victorion - RIDES","Inclusion Criteria:\n\nParticipant eligible for inclusion in this study must meet all the following criteria:\n\nAt Screening:\n\n1. Signed informed consent must be obtained prior to participation in the study.\n2. Males and females, ≥18 years of age at the time of providing written informed consent.\n3. Ability to understand study's requirements and provide informed consent and comply with all required study procedures.\n4. Hospitalization for a ACS event (STEMI or NSTEMI).\n5. Receiving treatment for the qualifying ACS event, according to clinical judgement, by means of medical treatment alone or percutaneous coronary revascularization.\n6. Had a successful PCI (with or without stent) for the qualifying event if a PCI was required.\n7. LDL-C value at the Screening visit measured by the local lab of:\n\n   * LDL-C ≥70 mg\u002FdL in participant previously treated with high-intensity statin (atorvastatin ≥40 mg\u002Fday or rosuvastatin ≥20 mg\u002Fday) or equivalent as per national guidelines and local regulation for at least 4 weeks before screening or\n   * LDL-C ≥100 mg\u002FdL in participant previously treated with low\u002Fmoderate-intensity statin for at least 4 weeks before screening or\n   * LDL-C ≥125 mg\u002FdL in participant previously not treated with statins for at least 4 weeks before screening, or who never received statins (including statin intolerant participants).\n\n   At Randomization:\n8. The participant must have a Baseline fasting LDL-C ≥70 mg\u002FdL (local lab assessment) to be eligible for randomization.\n9. Randomization within 7 days (≤ 7 days) following hospital admission for the qualifying ACS event and before\u002Fat discharge.\n\nExclusion Criteria:\n\nParticipant meeting any of the following criteria is not eligible for inclusion in this study.\n\nOnly for Japan: For exclusion criteria 6, investigator judgment should be documented in the source data document.\n\n1. Participant who is clinically unstable during hospitalization for the qualifying ACS event, defined by any of the following events within 24 hours prior to randomization:\n\n   * Hemodynamic instability: hypotension, defined as sustained systolic blood pressure of \\\u003C90 mmHg due to cardiac failure with associated symptoms requiring inotropes\n   * Arrhythmic events: Ventricular storm (e.g., torsade, ventricular tachycardia, ventricular flutter)\n   * Cardiogenic shock or mechanical complication of myocardial infarction\n   * New York Heart Association (NYHA) class IV heart failure\n   * Left ventricular ejection fraction \\\u003C20% at randomization (after all treatment procedures, based on the latest assessment of the LVEF using invasive or non-invasive assessment modalities)\n   * Uncontrolled severe hypertension: systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg prior to randomization despite antihypertensive therapy.\n2. Participant who has undergone or is scheduled to undergo CABG for treatment of the qualifying ACS event.\n3. Active liver disease defined as: (i) any known current infectious, neoplastic, or metabolic pathology of the liver or (ii) alanine aminotransferase (ALT) elevation \\>3x ULN or aspartate aminotransferase (AST) elevation \\>3x ULN, or total bilirubin elevation \\>2x ULN (except participant with Gilbert's syndrome) at the Screening visit, in the context of an ACS, and assessed as related to the index event and\u002For treatment procedures (such as PCI). Eligibility will be based on Investigator's judgement for participant who will be randomized.\n4. Renal insufficiency (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2) at the Screening visit.\n5. Fasting triglycerides value \\>400 mg\u002FdL (4.52 mmol\u002FL; assessed by local labs) at randomization visit.\n6. Participant, who based on the Investigator's judgement, could reach the LDL-C target value of \\\u003C55 mg\u002FdL after 4 weeks on statin treatment only.\n7. Secondary hypercholesterolemia (based on medical history).\n8. Homozygous familial hypercholesterolemia (based on medical history).\n9. Participant on apheresis at the Screening visit.\n10. Ongoing or medical history of myopathy at the Screening visit.\n11. CK values ≥5x ULN at Screening visit and confirmed by repeat test during Screening (local lab) , in the context of an ACS, and assessed as related to the index event and\u002For treatment procedures (such as PCI) eligibility will be based on Investigator's judgement for participant who will be randomized (who will be switched to or initiated on the protocol-specified dose of high-intensity statin of atorvastatin ≥40 mg QD or rosuvastatin ≥20 mg QD). Unless a more stringent CK value threshold is mandated by a local regulatory authority (e.g., ≥3x ULN in Korea according to MFDS internal guideline).",{"count":127,"type":21},300,[129],"PHASE3","The purpose of this trial is to learn about the effects of inclisiran in people with serious heart conditions (acute coronary syndromes), when this treatment is started early after hospital admission. To do this, researchers will test the effects of inclisiran compared to placebo, when given with standard treatment.",[27],[133,27,66,67,134,135,136,137],"KJX839","STEMI","Inclisiran","LDL-C","Hyperlipidemia","2026-08-07",{"date":81,"type":37},{"date":141,"type":37},"2025-10-03",{"date":143,"type":21},"2027-02-11",{"name":145,"class":146},"Novartis Pharmaceuticals","INDUSTRY",68,{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":161,"conditions":162,"keywords":176,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100612800","safety-and-clinical-performance-of-the-freesolve-resorbable-magnesium-scaffold-rms-system-in-subjects-with-coronary-artery-lesions-100612800","NCT07258290","Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions","Safety and Clinical Performance of the Drug Eluting Resorbable Coronary Magnesium Scaffold System (Freesolve) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries","BIOMAG-III","Clinical Inclusion Criteria:\n\n1. Subject is ≥ 18 years and ≤ 80 years of age\n2. Subject has provided written informed consent as approved by the Ethics Committee \u002F Institutional Review Board (IRB) of the respective clinical site prior to the study related procedures\n3. Subject is eligible for PCI according to the applicable guidelines\n4. Subject is an acceptable candidate for coronary artery bypass surgery\n5. Subjects with stable or unstable angina pectoris, documented silent ischemia\u002Fabnormal physiologic testing or hemodynamically stable non-ST elevation myocardial infarction (NSTEMI) patients without angiographic evidence of thrombus at target lesion\n\n   Note: STEMI patients may be eligible for the study for treatment of selected non-culprit lesions, if:\n   * Subject and target lesion(s) meet all inclusion and no exclusion criteria and consent occurs at least ≥ 72 hours after successful treatment of the culprit lesion(s) \\[lesion(s) causing the acute STEMI\\];\n   * Subject is hemodynamically stable with documented declining cardiac biomarkers;\n   * Target lesion(s) to be treated are not located in the culprit vessel(s) and are not culprit lesion(s)\n6. Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine\n7. Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to randomization)\n8. Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study\n\nAngiographic Inclusion Criteria:\n\n1. Subjects with a maximum of two single de novo target lesions each in separate native coronary arteries\n2. Target vessel must have a reference diameter between 2.5-4.2 mm by operator visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA) \u002F Intravascular Ultrasound (IVUS) \u002F Optical Coherence Tomography (OCT)\n3. Target lesion(s) must be ≤ 36 mm in length by operator visual estimation, which may be assisted by QCA \u002F IVUS \u002F OCT, (or \\\u003C 20 mm for target lesion(s) to be treated with a study device \\\u003C 3.0 mm in diameter) and must be amenable to treatment with a single study device\n4. Target lesion stenosis ≥ 50% and \\\u003C 100% by operator visual estimation, which may be assisted by QCA \u002F IVUS \u002F OCT. Target lesion stenosis \\\u003C 70% by visual estimation, should have clinical justification for treatment as per local standards.\n5. Target lesion must have a Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 1\n\nClinical Exclusion Criteria:\n\n1. Subject is pregnant and\u002For breastfeeding or intends to become pregnant during the duration of the study\n2. Subject has clinical symptoms and\u002For electrocardiogram (ECG) changes consistent with STEMI \\\u003C 72 hours prior to the index procedure Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment\n3. Subject has undergone prior PCI within the target vessel during the last 12 months prior to the index procedure or prior PCI within a non-target vessel \\\u003C 72 hours prior to the index procedure\n4. Subject is on dialysis or has impaired renal function (serum creatinine \\> 2.5 mg\u002FdL or 221 µmol\u002FL, determined within 7 days prior to the index procedure)\n5. Subject has a known allergy to contrast medium that cannot be adequately premedicated, or any known allergy to aspirin, P2Y12 inhibitors, both heparin and bivalirudin, sirolimus, everolimus (or similar limus drugs), poly L-lactide, the scaffold material (magnesium, aluminum, tantalum), or Xience stent material (cobalt, chromium, tungsten, nickel, methacrylic polymer, and fluoropolymer)\n6. Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted)\n7. Life expectancy less than 1 year\n8. Planned surgery or dental surgical procedure within 6 months after index procedure, unless DAPT can be maintained\n9. In the investigator's opinion subject will not be able to comply with the follow-up requirements\n10. Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e., triple therapy) can be maintained for a minimum of 1 month\n11. Subject has had a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure\n12. Subject with active bleeding disorder, active coagulopathy, or any other reason, who is ineligible for DAPT\n13. Subject is currently participating or plans to participate in another study with an investigational device or an investigational drug\n14. Subject has known severe aortic or mitral valve stenosis\u002Finsufficiency or has previously undergone transcatheter aortic valve replacement (TAVR)\n\nAngiographic Exclusion Criteria:\n\n1. Target vessel has been previously treated and the target lesion is within 5 mm proximal or distal to the previously treated lesion\n2. Left main coronary artery disease\n3. Target lesion is totally occluded (100% stenosis)\n4. Thrombus in target vessel\n5. Future planned staged PCI either in target or non-target vessel\n6. Ostial target lesion within the left anterior descending (LAD), left circumflex (LCX), or right coronary artery (RCA) (within 5.0 mm of vessel origin)\n7. Target lesion involves a side branch ≥ 2.0 mm in diameter that requires a two-device strategy after pre-dilatation\n8. Target lesion is located in or supplied by an arterial or venous bypass graft\n9. Target lesion with excessive tortuosity proximal to or within the lesion based on visual estimation or heavily calcified target lesion which cannot be adequately pre-dilated by a non-compliant and\u002For cutting\u002Fscoring balloon as described in angiographic exclusion criteria 10\n10. Target lesion requires treatment with a device other than the non-compliant balloon and\u002For cutting\u002Fscoring balloon prior to scaffold\u002Fstent placement (including but not limited to atherectomy devices, intravascular lithotripsy, drug-coated balloons, etc.)\n11. Target vessel was treated with brachytherapy any time prior to the index procedure.\n12. Unsuccessful pre-dilatation, defined as residual stenosis \\> 20% (by visual estimation) and\u002For angiographic complications (e.g., distal embolization, side branch closure, flow-limiting dissections)","80 Years",{"count":158,"type":21},1859,[160],"NA","The objective of this study is to assess the safety and efficacy of the Freesolve resorbable magnesium scaffold (RMS) in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to the Xience coronary drug-eluting stent (DES) system",[163,164,165,166,167,168,169,170,171,172,173,104,174,27,175],"Coronary Disease","Heart Diseases","Cardiovascular Diseases","Arteriosclerosis","Arterial Occlusive Diseases","Vascular Diseases","Chest Pain","Pain","Neurologic Manifestations","Signs and Symptoms","Pathological Conditions, Signs and Symptoms","Myocardial Ischemia","Angina Pectoris",[177,178,179,180],"Resorbable Magnesium Scaffold","Sirolimus","RMS","Drug eluting absorbable metal scaffold","2026-07-23",{"date":183,"type":37},"2026-07-24",{"date":185,"type":37},"2026-06-11",{"date":187,"type":21},"2033-06",{"name":189,"class":146},"Teleflex",2,{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":207,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":190},"100648509","intrahospital-influenza-vaccination-in-patients-at-high-cardiovascular-risk-vacc-up-100648509","NCT07721649","Intrahospital Influenza Vaccination in Patients at High Cardiovascular Risk (VACC-UP)","Intrahospital Vaccination and Active Counseling Versus Active Counseling Alone to Increase Seasonal Influenza immUnization in Patients at High Cardiovascular Risk in Germany: The Randomized Controlled VACC-UP Study","VACC-UP","Inclusion Criteria:\n\n* Age 18 years or older\n* Hospitalized due to acute coronary syndrome (ACS) or congestive heart failure (CHF) and fulfilling the criteria for influenza vaccination according to the recommendations of the German Standing Vaccination Committee (STIKO)\n* Written informed consent\n\nExclusion Criteria:\n\n* Already received seasonal influenza vaccination in the current season, based on self-reported vaccination status and\u002For vaccination certificate\n* Laboratory-confirmed active influenza infection during the index hospitalization\n* Contraindication for vaccination (e.g., known allergy)\n* Inability to provide written informed consent",{"count":200,"type":21},482,[160],"The aim of this study is to evaluate the effect of offering intrahospital influenza vaccination as an adjunct to active counseling during the index hospitalization to adult patients hospitalized for acute coronary syndrome (ACS) or congestive heart failure (CHF), compared with active counseling alone, on influenza vaccination rates in patients at high cardiovascular risk.\n\nPatients are randomized 1:1 to either an offer of bedside intrahospital influenza vaccination according to the recommendations of the German Standing Vaccination Committee (STIKO) in addition to standardized active counseling (intervention group), or standardized active counseling plus the standard-of-care recommendation for ambulatory vaccination in the discharge papers (control group). The primary endpoint is the influenza vaccination rate at the end of the index season (March 31).",[27,204,205,165,206],"Heart Failure","Influenza, Human","Vaccination Refusal",[208,209,210,211,212,213,214,215,216],"Influenza vaccination","Vaccination rate","Intrahospital vaccination","Acute coronary syndrome","Congestive heart failure","Health services research","Vaccine hesitancy","7C psychological antecedents of vaccination","Cardiovascular prevention","2026-07-18",{"date":181,"type":37},{"date":220,"type":21},"2026-09",{"date":222,"type":21},"2029-06",{"name":224,"class":44},"Stephan Baldus",{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":235,"briefSummary":237,"conditions":238,"keywords":239,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":190},"100595433","phase-2-a-polypill-for-acute-coronary-syndrome-100595433","NCT07032389","A Polypill for Acute Coronary Syndrome","Polypill Strategy for the Treatment of Patients After Acute Coronary Syndromes - A Multicenter Randomized Controlled Trial","PolyACS","Inclusion Criteria:\n\n* Age ≥ 18\n* Hospitalization for acute coronary syndrome with percutaneous coronary intervention\n* Discharged on aspirin, prasugrel or clopidogrel, and a high-intensity statin\n\nExclusion Criteria:\n\n* Current need for systemic anticoagulation\n* Contraindication to receive any components of the polypill\n* History of allergic reaction or intolerance to aspirin, prasugrel or clopidogrel, or rosuvastatin\n* Comorbidities that might be expected to limit lifespan within the 12-month study period\n* Increased risk of bleeding or planned urgent surgery that would necessitate use of DAPT for \\\u003C 12 months\n* Inability to provide written informed consent\n* Pregnancy",{"count":234,"type":21},1000,[236],"PHASE2","The current study aims to investigate whether combining the standard medications prescribed after acute coronary syndrome (ACS)-aspirin, P2Y12 inhibitors, and statins-into a single polypill can improve outcomes following an ACS event. Although these therapies are effective, gaps in adherence and uptake significantly contribute to risk or adverse events in the post-ACS period. This study is designed as a pragmatic, multi-center, randomized trial to assess the feasibility and effectiveness of a polypill-based strategy for treatment of ACS.",[27],[27,240,241],"Polypill","Adherence","2026-07-08",{"date":244,"type":37},"2026-07-10",{"date":246,"type":37},"2025-12-05",{"date":248,"type":21},"2030-07-31",{"name":250,"class":44},"University of Texas Southwestern Medical Center",{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":89},"100541668","effectiveness-of-a-resilience-based-rehabilitation-program-for-patients-with-coronary-heart-disease-100541668","NCT06332859","Effectiveness of a Resilience-Based Rehabilitation Program for Patients With Coronary Heart Disease","Effectiveness of a Resilience-based Rehabilitation Program in Patients With TakoTsubo Cardiomyopathy and After Acute Coronary Syndrome","Inclusion Criteria:\n\n* patients experienced TakoTsubo cardiomyopathy (I42.88, I42.9) or patients after an acute coronary event (I21.9) (max. 6 month post event)\n* older than 18 years\n* signed consent form\n\nExclusion Criteria:\n\n* Acute intercurrent illness (longer than 3 days)\n* No sufficient knowledge of German to enable participation in the resilience training (assessment by recruiting person)",{"count":259,"type":21},130,[160],"To handle daily life challenges, one needs to be psychologically resilient. It plays a crucial role in disease development, prognosis, as well as social, occupational, and community participation. Cardiovascular diseases cause physical and psychological stress, which can be linked to individual resilience and the development of such diseases. Stress can trigger TakoTsubo cardiomyopathy and acute coronary events. Individuals who have experienced TakoTsubo cardiomyopathy or an acute coronary event often feel stressed due to emotional or physical triggers. These triggers may include job loss or illness. In medical rehabilitation, therapists consider the individual circumstances of their patients when planning therapy. It may be important to add a special focus on psychological care, including building resilience, which could greatly benefit these individuals. Therefore, the study aims to investigate whether resilience training, as part of an inpatient multidisciplinary rehabilitation program, affects the individual resilience of rehabilitants with TakoTsubo cardiomyopathy or those who have experienced an acute coronary event.",[263,27,264],"Takotsubo Cardiomyopathy","Psychological Resilience","2026-07-07",{"date":267,"type":37},"2026-07-09",{"date":269,"type":37},"2024-04-15",{"date":271,"type":21},"2026-10-14",{"name":273,"class":44},"Pensionsversicherungsanstalt",{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":283,"briefSummary":284,"conditions":285,"keywords":287,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":301},"100156656","revascularization-strategies-in-patients-with-non-st-segment-elevation-acute-coronary-syndrome-nste-acs-and-severe-coronary-artery-disease-100156656","NCT01311323","Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease","Multivessel and Left Main Coronary Artery Stenting in Comparison With Surgical Revascularization in Patients With Non ST Elevation Acute Coronary Syndrome. Prospective, Clinical Randomized Trial (The MILESTONE Trial)","MILESTONE","Inclusion Criteria:\n\nSubjects must meet ALL of the inclusion criteria to be considered for the trial. If ANY of the exclusion criteria are met, the subject is excluded from the trial and cannot be randomized.\n\n* Age over 18 years,\n* Written patient consent,\n* Acute Coronary Syndrome without ST-segment elevation of high, intermediate and low risk, including NSTEMI and unstable angina requiring urgent (within 72 hours) invasive strategy,\n* Qualification for invasive treatment,\n* Multivessel coronary disease, defined as angiographic narrowing \\>50%DS on investigator's visual assessment in at least two major coronary artery territories (RCA, LAD, LCX), including involvement of the proximal segment of the left anterior descending artery or three-vessel disease with a Syntax Score \\\u003C 33. Intermediate lesions (40-70%) will need to be assessed with either FFR, iFR, or VFFR). Patient may have left main coronary artery disease, defined as narrowing \\>50%DS (but this is not obligatory). For borderline changes, IVUS (MLA \\\u003C6 mm2 or iFR=\\\u003C0,90 or FFR=\\\u003C0,80, with an anatomic Syntax Score \\\u003C33 will be decisive,\n* Feasibility of complete revascularization on both the CABG and PCI sides,\n* Consent within the Heart Team for both CABG by the cardiothoracic surgeon and PCI by the interventional cardiologist.\n\nExclusion Criteria:\n\n* Age under 18 years,\n* ST-segment elevation myocardial infarction (STEMI) or new left bundle branch block (LBBB),\n* Stable coronary syndrome,\n* Single- or two-vessel coronary disease without involvement of the proximal LAD, defined as narrowing above 50%DS,\n* Qualification for conservative treatment,\n* Anticipated surgery other than CABG due to severe valvular defect or other structural defect, particularly moderate or severe mitral regurgitation,\n* Need for immediate coronary angioplasty treatment,\n* Syntax Score equal or above 33 (\\>=33),\n* Contraindications to short-term and long-term antiplatelet therapy,\n* Acute heart failure in class IV (cardiogenic shock),\n* Previous CABG procedure,\n* Previous PCI procedure within the last 6 months,\n* Ischemic or hemorrhagic stroke within 6 months prior to inclusion,\n* End-stage chronic kidney disease on dialysis,\n* Pregnancy or intention to become pregnant (women of child bearing age must have a recent negative pregnancy test prior to randomization),\n* Non cardiac co-morbidities with life expectancy less than 3 years,\n* Participation in other clinical trial that have not reached their primary endpoint.",{"count":234,"type":21},[160],"MILESTONE STUDY is dedicated to problems connected with patients with multivessel coronary artery disease and\u002For with left main narrowing who present symptoms of acute ischemia. For such kind of patients according to current ACC\u002FAHA guidelines CABG (surgical revascularization) is recommended as a treatment method. In comparison with CABG, recent studies have shown that PCI (percutaneous coronary intervention) is associated with a lower rate of periprocedural adverse events and similar long term event-free survival in patients with left main disease. Our latest non randomized registry and randomized LEMANS study, comparing LMCA (left main coronary artery) stenting with CABG confirmed above findings. LEMANS ACS (acute coronary syndrome) retrospective registry of patients with UPLMCA (unprotected LMCA) disease and non ST elevation ACS showed lower 30 day and trend toward lower one year mortality after PCI when compared with CABG. It should be stressed, that acute ischemia substantially increase the risk of CABG. In fact, there are limited data on the outcome of ULMCA stenting or CABG in patients with acute coronary syndromes (ACS).\n\nSimilarly, all randomized studies comparing PCI vs CABG in multivessel disease included mainly patients with stable angina, small cohort of patients with unstable angina and they excluded patients with non ST elevation Myocardial infarction.\n\nIn the SYNTAX study -largest PCI vs CABG trial, randomized patients were patients with low perioperative risk (logistic EUROSCORE \\\u003C5) and ACS patients routinely excluded. High perioperative risk patients were included only in PCI registry.",[286,27],"Multivessel Coronary Artery Disease",[286,288,105,289,290,291,292,293],"Left Main Narrowing","Coronary Artery Bypass Grafting","Drug-Eluting Stent","Fractional Flow Reserve","Instant wave-free ratio","virtual Fractional Flow Reserve",{"date":242,"type":37},{"date":296,"type":37},"2025-08-25",{"date":298,"type":21},"2030-11",{"name":300,"class":44},"American Heart of Poland",9,{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":309,"enrollmentInfo":310,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":312,"conditions":313,"keywords":314,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":4},"100646997","phase-4-comparative-assessment-of-inclisiran-on-top-of-standard-of-care-versus-standard-of-care-alone-for-ldl-c-evaluation-in-acute-coronary-syndrome-patients-in-saudi-arabia-100646997","NCT07684469","Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia","Comparative, Randomized, Multicenter, Followed by an Open Label Extension Trial in Patients With a Recent Acute Coronary Syndrome Evaluating the Early Inclusion of Inclisiran Into Standard of Care Versus Standard of Care Alone in Kingdom of Saudi Arabia","Inclusion Criteria:\n\nParticipants eligible for inclusion in this study must meet all of the following criteria:\n\n1. Males and females ≥18 years of age.\n2. Recent ACS (in-patient\u002Fout-patient) within 7 days of index admission, as per 2023 ESC guidelines for the management of acute coronary syndrome\n3. Serum LDL-C ≥1.8 mmol\u002FL (≥70 mg\u002FdL) or non-HDL ≥100 mg\u002FdL at screening for participants who were receiving SOC \\[including lipid lowering therapy and\u002For ezetimibe\\] prior enrollment.\n4. Serum LDL-C ≥2.6 mmol\u002FL (≥100 mg\u002FdL) or non-HDL ≥124 mg\u002FdL at screening for participants who were SOC treatment naïve prior enrollment.\n5. Fasting triglycerides \\\u003C4.52 mmol\u002FL (\\\u003C400 mg\u002FdL) at screening.\n6. Estimated glomerular filtration rate (eGFR) \\>30 mL\u002Fmin at screening.\n7. Participants must be willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria are not eligible for inclusion in this study:\n\n1. Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study and\u002For put the participant at significant risk (according to investigator's \\[or delegate\\] judgment) if he\u002Fshe participates in the clinical study.\n2. An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.\n3. New York Heart Association (NYHA) class IIIb or IV heart failure or last known left ventricular ejection fraction \\\u003C25%.\n4. Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening.\n5. Uncontrolled severe hypertension: systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg prior to randomization (assessed at screening visit) despite antihypertensive therapy.\n6. Homozygous familial hypercholesterolemia (HoFH) defined as LDL-C ≥ 12 mmol\u002FL.\n7. Statin intolerant patients defined as documented side effects on 2 different statins, including one at the lowest standard dose.\n8. Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.\n9. History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and\u002For systemic therapy during the three years prior to randomization.\n10. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In the case of oophorectomy alone, the reproductive status of the woman needs to have been confirmed by follow-up hormone level assessment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and\u002For age-appropriate history of vasomotor symptoms).\n11. Breastfeeding women.\n12. Treatment with other investigational products or devices within 30 days or five half-lives of the screening visit, whichever is longer.\n13. History of hypersensitivity to any of the study treatments or its excipients, or to drugs of similar chemical classes (statins, ezetimibe, and inclisiran).\n14. Planned use of other investigational products or devices during the course of the study.\n15. Any condition that, according to the investigator, could interfere with the conduct of the study, such as but not limited to:\n\n    1. Participants who are unable to communicate or to cooperate with the investigator.\n    2. Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including participants whose cooperation is doubtful due to drug abuse or alcohol dependency).\n    3. Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study).\n    4. Persons directly involved in the conduct of the study.\n16. Treatment with monoclonal antibodies directed towards PCSK9 or inclisiran within 60 days of screening or planned use of it as SOC during next 210 days.\n17. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or (ii) alanine aminotransferase (ALT) elevation \\>3x ULN, aspartate aminotransferase (AST) elevation \\>3x ULN, or total bilirubin elevation \\>2x ULN (except patients with Gilbert's syndrome) at screening confirmed by a repeat measurement at least one week apart.\n18. Uncontrolled Diabetes Mellitus (DM) defined as HbA1c \\> 9%.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply","100 Years",{"count":127,"type":21},[101],"This study aims to evaluate the effectiveness and safety of implementing a systematic augmented low-density lipoprotein cholesterol (LDL-C) management care pathway initiated in hospitals for patients with Acute Coronary Syndrome. This pathway includes treatment with inclisiran on top of the standard of care (SOC), which consists of statins with or without ezetimibe, compared to a high-intensity SOC regimen alone (statins +\u002F- ezetimibe).",[27],[137,315,316],"Recent acute coronary syndrome","Lipid lowering therapies","2026-06-29",{"date":319,"type":37},"2026-07-06",{"date":321,"type":21},"2026-06-30",{"date":323,"type":21},"2028-10-31",{"name":145,"class":146},{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":16,"minAge":333,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":22,"phases":336,"briefSummary":337,"conditions":338,"keywords":340,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":360},"100394478","phase-4-potassium-competitive-acid-blocker-versus-proton-pump-inhibitor-for-gastroprotection-strategies-in-patients-at-high-gastro-intestinal-bleeding-risk-receiving-antithrombotic-therapy-100394478","NCT04416581","Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy","A Multi-centre, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Phase 4 Efficacy and Safety Study of P-CAB (Tegoprazan 50 mg Once Daily) Compared With PPI (Rabeprazole 20 mg Once Daily) to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease","PROTECT-HBR","Inclusion Criteria:\n\n1. Patients 19 years of age or older with known cardiac and vascular disease who are receiving chronic use of antithrombotic drugs (either antiplatelets, oral anticoagulant (OAC), and its combinations). Specific clinical conditions that may confer a need for long-term antithrombotic therapy may include documented coronary artery disease (stable or unstable angina, acute coronary syndrome, a history of myocardial infarction, or any coronary revascularization), documented cerebrovascular disease (stroke or transient ischemic attack), known peripheral arterial disease or a history of peripheral arterial revascularization, atrial fibrillation, or valvular heart disease requiring interventions (transcatheter aortic valve replacement or transcatheter mitral-valve repair). Concomitant use of a proton pump inhibitor is strongly recommended in patients receiving aspirin monotherapy, DAPT (dual antiplatelet therapy; aspirin plus any P2Y12 inhibitors), DAT (dual antithrombotic therapy; antiplatelet drug plus OAC), TAT (triple antithrombotic therapy; DAPT plus OAC), or OAC monotherapy (warfarin or direct oral anticoagulants) who are at high risk of GI bleeding in order to reduce the risk of gastric bleed or GI events. Based on clinical guidelines, the use of P2Y12 inhibitor monotherapy (i.e. clopidogrel, ticagrelor, or prasugrel) is not considered in trial enrollment.\n2. On the basis of clinical guidelines and expert consensus documents, we defined a study population with an increased risk of gastrointestinal bleeding if they had a least 1 or more criteria of the following characteristics. Eligible patients for randomization must meet at least 1 characteristic of these criteria:\n\n   \\*Definition of patients who are at high risk of gastrointestinal bleeding\n   1. Age ≥65 years\n   2. Concomitant use of OAC and any antiplatelet therapy (mono or DAPT) (i.e., DAT or TAT)\n   3. Long-term use of oral NSAIDs (non-steroidal anti-inflammatory drugs) or steroids or high-dose NSAID therapy even during a relatively short-term period.\n   4. History of prior GI bleeding events at any time\n   5. History of a previously complicated ulcer\n   6. History of peptic ulcer disease or a previously uncomplicated ulcer\n   7. Documented Helicobacter pylori infection\n3. Patients who voluntarily participated in the written agreement\n\nExclusion Criteria:\n\n1. Active bleeding at the time of inclusion or a history of hereditary or acquired hemostatic disorder\n2. Any clinical contraindication to using of antithrombotic therapies (antiplatelet agents or OAC)\n3. Concurrent use of PPI or P-CAB within 4 weeks before randomization\n4. Hemodynamically unstable conditions at the time of inclusion: cardiogenic shock at the time of randomization, refractory ventricular arrhythmias, or congestive heart failure (New York Heart Association class IV).\n5. Baseline severe anemia (Hgb \\\u003C8 g\u002Fdl at baseline) or transfusion within 4 weeks before randomization\n6. Baseline severe thrombocytopenia (platelet count \\\u003C50,000\u002Fmm3)\n7. Renal failure dependent on dialysis or severe renal insufficiency (creatinine clearance \\\u003C15 ml\u002Fmin)\n8. Severe chronic liver disease (defined as variceal haemorrhage, ascites, hepatic encephalopathy, or jaundice)\n9. Hypersensitivity or contraindication to PPI, P-CAB, any of the product components, or substituted benzimidazoles\n10. Use of clarithromycin and hypersensitivity to macrolide antibiotics for Helicobacter pylori eradication\n11. Concomitant use of clarithromycin with terfenadine, cisapride, astemizole, or pimozide for Helicobacter pylori eradication\n12. Systemic treatment with strong CYP 3A4 and p-glycoprotein (P-GP) inhibitors (e.g., systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus \\[HIV\\]-protease inhibitors, such as ritonavir)\n13. Patients who take atazanavir, nelfinavir, or rilpivirine-containing products (see Drug-Drug interaction section)\n14. Clinically significant laboratory abnormality at screening (estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin or elevated liver enzyme \\[AST, ALT, ALP, total bilirubin\\] \\> 3 times upper normal limit \\[UNL\\] or any other condition that, in the opinion of the Investigator, precludes participation in the study\n15. Any known or suspected malignancy\n16. Patients with non-cardiac co-morbidities with a life expectancy of less than 12 months\n17. Patients with active treatment for H-pylori infection\n18. Women who are pregnant or breastfeeding or female subjects, premenopausal who are not surgically sterile, or, if sexually active not practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, who have a positive pregnancy test at screening\n19. Participation in another clinical study within 12 months. However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion;\n\n    1. Participated in the observational study expected no effect on the safety and\u002For effectiveness evaluation of this trial\n    2. Screening failed before any interventional factor is involved\n    3. Participated in academic trials like strategic or medical device comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies","19 Years",{"count":335,"type":21},3320,[101],"The primary aim of this study is to evaluate the efficacy and safety of novel P-CAB (tegoprazan 50 mg once daily) as compared with standard PPI (rabeprazole 20 mg once daily) for protection of GI events in patients with known cardiac and vascular disease receiving chronic use of antithrombotic drugs (either antiplatelets, OAC, and its combinations) who are at high GI bleeding risk. The primary hypothesis is that P-CAB (experimental arm) would non-inferior to PPI (standard arm) with respect to the rate of the primary composite end point of GI events at 12 months after randomization.",[104,105,27,339],"Myocardial Infarction",[341,342,343,29,344,345,346,347,348,349,350],"gastroduodenal ulcer","gastrointestinal hemorrhage","peptic ulcer","coronary artery stent placement","antiplatelet","anticoagulant therapy","PPI","P-CAB","Proton-pump inhibitors","Potassium-Competitive Acid Blockers","2026-06-24",{"date":353,"type":37},"2026-06-26",{"date":355,"type":37},"2021-05-12",{"date":357,"type":21},"2028-02-28",{"name":359,"class":44},"Duk-Woo Park, MD",45,{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":368,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":371,"conditions":372,"keywords":376,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":89},"100545664","diagnostic-performance-of-artificial-intelligence-algorithms-in-prediction-of-acute-coronary-syndrome-based-on-white-blood-cell-properties-100545664","NCT06384846","Diagnostic Performance of Artificial Intelligence Algorithms in Prediction of Acute Coronary Syndrome Based on White Blood Cell Properties","Diagnostic Performance of Artificial Intelligence Algorithms in Prediction of Acute Coronary Syndrome Based on White Blood Cell Properties (AI-ACS Trial)","Inclusion Criteria:\n\nGeneral inclusion criteria:\n\n* Male or female, aged 18 years or above.\n* Participant is willing and able to give informed consent for participation in the study.\n* Collection of WBC and hs-cTn data must be possible.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled, where applicable.\n\nCase cohort:\n\n* Suspicion of STEMI or NSTE-ACS according to current ESC guidelines.\n* Coronary angiography must have been performed within 72 hours after initial suspicion of ACS.\n* For patients qualifying for observation according to ESC guidelines, coronary angiography is not mandatory and time limits do not apply.\n* Confirmation of STEMI or NSTE-ACS by identification of a culprit lesion using coronary angiography; identical evaluation results by review board required.\n* For observation patients without coronary angiography, final discharge diagnosis is used to decide about the presence or absence of NSTEMI and\u002For ACS.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled.\n\nControl cohort:\n\n* Suspicion of STEMI or NSTE-ACS according to current ESC guidelines.\n* Coronary angiography must have been performed within 72 hours after initial suspicion of ACS.\n* No identification of a culprit lesion compatible with diagnosis of STEMI or NSTE-ACS during coronary angiography; identical evaluation results by review board required.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled.\n\nSupplementary cohort:\n\n* Subject presents without chest pain or with stable angina pectoris.\n* No indication for revascularization during coronary angiography; identical evaluation results by review board required.\n* Exclusion of elevated hs-cTn.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled.\n* Between initial blood sampling to collect WBC data and coronary angiography, the subject must not develop suspicion of ACS.\n\nRule-out cohort:\n\n* Suspicion of NSTE-ACS and NSTEMI rule-out according to current ESC guidelines, i.e. very low initial hs-cTn value, or low initial hs-cTn value and no significant 1-hour\u002F2-hour change in hs-cTn value.\n* No coronary angiography within 72 hours.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled.\n\nAll-comer cohort:\n\n* Subject presents to the emergency department with suspected ACS.\n* Clinical assessments, ECG, and measurements of hs-cTn, single or serial measurement, must be conducted according to ESC guidelines.\n* Collection of WBC data must be performed at initial blood withdrawal after admission to the emergency department.\n* Review board evaluations must confirm the presence or absence of a culprit lesion if coronary angiography was performed, as outlined for the case and control cohorts.\n\nExclusion Criteria:\n\n* Age below 18 years.\n* Subject refuses informed consent.\n* Collection of WBC and hs-cTn data is not possible.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data cannot be fulfilled.\n* Suspicion of ACS occurs in subjects with no or stable angina pectoris any time between initial blood sampling and start of coronary angiography.",true,{"count":370,"type":21},3350,"The goal of this observational study is to evaluate whether artificial intelligence (AI) algorithms can predict or exclude acute coronary syndrome (ACS) in adults using data generated by routine hematology testing. The main questions the study aims to answer are:\n\n* Can AI algorithms based on white blood cell (WBC) data predict or exclude ACS in subjects with suspected ACS?\n* Can erythrocyte (EC) and\u002For thrombocyte (TC) data, where available, improve or complement WBC-based AI prediction of ACS?\n* How does the diagnostic performance of the AI algorithms compare with high-sensitivity cardiac troponin (hs-cTn), and can the combination of AI algorithms and hs-cTn improve diagnostic performance?\n\nParticipants will undergo clinical assessment and blood testing as part of usual clinical care. Their previously generated clinical information, hematology data, and hs-cTn results will be used to train and test the AI algorithms. Participation in the study does not determine the indication for coronary angiography or treatment, and no additional study-specific treatments are performed.",[27,175,373,374,375],"NSTEMI - Non-ST Segment Elevation MI","STEMI - ST Elevation Myocardial Infarction","Unstable Angina (UA)",[377,378,379,66,380,381,382],"Artificial Intelligence","AI","hematology analyzer","white blood cell","Troponin","Machine learning","2026-06-21",{"date":351,"type":37},{"date":386,"type":37},"2024-02-01",{"date":388,"type":21},"2026-12-31",{"name":390,"class":146},"RobotDreams GmbH",{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":397,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":16,"minAge":399,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":22,"phases":402,"briefSummary":403,"conditions":404,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":414},"100509855","phase-3-effect-of-dalcetrapib-on-cv-risk-in-a-genetically-defined-population-with-a-recent-acs-100509855","NCT05918861","Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS","Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS)","dal-GenE-2","Inclusion Criteria:\n\n* Subjects with the appropriate genetic background and recently hospitalized for ACS (up to 3 months following the index event), will be enrolled in this trial.\n* Both male and female subjects age 45 years and over at screening visit (V1)\n* AA genotype at variant gene as determined by Genotype Assay Test, conducted at a designated investigational testing site (ITS)\n* Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization\n* Prior to randomization, subjects must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment.\n* Randomization within 3 months of the index ACS event\n\nExclusion Criteria:\n\n* Females who are pregnant (negative urine pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding\n* Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for \\>12 months) who are not using at least one highly effective method of contraception.\n* New York Heart Association (NYHA) Class III or IV heart failure\n* Index ACS event presumed due to uncontrolled hypertension\n* Systolic blood pressure (BP) \\>180 mmHg and\u002For diastolic blood pressure \\>110 mmHg at the time of randomization despite anti-hypertensive therapy\n* Subjects with clinically apparent liver disease, eg, jaundice, cholestasis, hepatic synthetic impairment, active hepatitis or last known ALT or AST level \\>3 x ULN within 6 months prior to randomization (excluding index event)\n* History of persistent and unexplained creatine phosphokinase (CPK) levels \\> 5 times the ULN as assessed within 6 months prior to randomization (excluding index event)\n* Last known eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2 as assessed within 6 months prior to randomization\n* History of malignancy or any other significant comorbidity, the prognosis or management of which is likely to interfere with study conduct or subjects with a life expectancy of less than 3 years.\n* Presence of any last known laboratory value as evaluated prior to randomization that is considered by the investigator to potentially limit the patient's successful participation in the study\n* Subjects who have received any investigational drug within 1 month of randomization, or who expect to participate in any other investigational drug or device study during the conduct of this trial\n* Subjects who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization","45 Years",{"count":401,"type":21},2000,[129],"This is a placebo-controlled, randomized, double-blind, parallel group, phase 3 multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. A separate informed consent will be allowed for an initial pre-screening genetic testing. Subjects meeting the AA genotype will then consent to the full study and confirmatory genetic testing as required. Subject enrollment may begin in the hospital and will continue following release from the hospital or may begin following release from hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (up to12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.",[27],"2026-06-17",{"date":407,"type":37},"2026-06-22",{"date":409,"type":37},"2023-10-03",{"date":411,"type":21},"2027-08",{"name":413,"class":146},"DalCor Pharmaceuticals",231,{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":431,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":89},"100415858","phase-4-dual-antithrombotic-therapy-with-dabigatran-and-ticagrelor-in-patients-with-acs-and-non-valvular-af-undergoing-pci-100415858","NCT04695106","Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With ACS and Non-valvular AF Undergoing PCI","Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With Acute Coronary Syndrome and Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (ADONIS-PCI)","ADONIS-PCI","Inclusion Criteria:\n\n* Male and female patients aged ≥18 years'\n* Patients with new-onset or pre-existing non-valvular AF that have been receiving oral anticoagulant treatment with dabigatran for at least 48 hours or were treatment naïve prior to PCI. AF may be paroxysmal, persistent or permanent, but must not be secondary to a reversible disorder such as MI, pulmonary embolism, recent surgery, pericarditis or thyrotoxicosis unless long-term treatment with an OAC is anticipated.\n* Patients presenting with ACS that had undergone a successful PCI with drug-eluting stent (DES) implantation or plain old balloon angioplasty within the previous 120 hours. ACS may be ST-elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), or unstable angina (UA). Successful treatment with PCI is defined as achievement of \\\u003C30% residual diameter stenosis of the target lesion assessed by visual inspection or quantitative coronary angiography and no in-hospital major adverse cardiac events (AMI or repeat coronary revascularisation of the target lesion). For ACS patients with ST-segment elevation, persistent ST-segment elevation of at least 0.1 mV in at least two contiguous leads or a new left bundle-branch block should be present. For ACS patients without ST-segment elevation, at least two of the following three criteria should be met: (i) ST-segment changes on electrocardiography, indicating ischemia; (ii) a positive test of a biomarker, indicating myocardial necrosis; or (iii) one of several risk factors (age ≥60 years; previous myocardial infarction or coronary artery bypass grafting; coronary artery disease with stenosis of ≥50% in at least two vessels; previous ischemic stroke, transient ischemic attack, carotid stenosis of at least 50%, or cerebral revascularization; diabetes mellitus; peripheral arterial disease; chronic renal dysfunction, defined as a creatinine clearance of \\\u003C60 ml per minute per 1.73 m2 of body surface area).\n* The patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and\u002For regulations.\n\nExclusion Criteria:\n\n* Mechanical or biological heart valve prosthesis;\n* PCI with bare-metal stent insertion;\n* Unsuccessful PCI (\\>30% residual stenosis of the target lesion);\n* Cardiogenic shock during current hospitalization;\n* Adverse bleeding or ischaemic event during current hospitalization;\n* Anaemia (haemoglobin \\\u003C10 g\u002FdL) or thrombocytopenia (platelet count \\\u003C100 x109\u002FL) at screening,\n* Severe renal impairment (creatinine clearance \\\u003C30mL\u002Fmin (estimated CrCl calculated by Cockcroft-Gault equation) at screening;\n* Active liver disease at screening defined as persistently elevated alanine aminotransferase (ALT) or aspartate transaminase (AST) \\>3-fold upper limit of normal (ULN)\n* Use of fibrinolytic agents within 24 hours of screening;\n* Gastrointestinal bleeding within 1 month prior to screening unless, in the opinion of the Investigator, the cause has been permanently eliminated (e.g., by surgery);\n* Major bleeding episode (reduction in the hemoglobin level of at least 2 g\u002FdL, transfusion of at least two units of blood, or symptomatic bleeding in a critical area or organ), including life-threatening bleeding episode (symptomatic intracranial bleeding, bleeding with a decrease in the hemoglobin level of at least 5 g\u002FdL or bleeding requiring transfusion of at least 4 units of blood or inotropic agents or necessitating surgery) within 1 month prior to screening;\n* Stroke within 1 month prior to screening;\n* Major surgery within 1 month prior to screening;\n* Malignancy or radiation therapy within 6 months prior to screening unless, in the opinion of the Investigator, the estimated life expectancy is greater than 36 months;\n* History of intraocular, spinal, retroperitoneal, or traumatic intra-articular bleeding unless the causative factor has been permanently eliminated or repaired;\n* Hemorrhagic disorder or bleeding diathesis (e.g. von Willebrand disease, hemophilia A or B or other hereditary bleeding disorder, history of spontaneous intra-articular bleeding, history of prolonged bleeding after surgery\u002Fintervention);\n* Past an organ transplant or patient on the waiting list for organ transplant;\n* Need for continued treatment with systemic ketoconazole, itraconazole, posaconazole, cyclosporine, tacrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. John's Wort or any cytotoxic\u002Fmyelosuppressive therapy.\n* Need for continued treatment with non-steroidal anti-inflammatory drugs (NSAIDs);\n* Pre-menopausal women (last menstruation ≤1 year prior to screening) who: sre pregnant or breastfeeding or are not surgically sterile or are of childbearing potential and not practicing two acceptable methods of birth control, or do not plan to continue practicing an acceptable method of birth control throughout the trial. Acceptable methods of birth control are oral or parenteral (patch, injection, implant) hormonal contraception, which has been used continuously for at least one month prior to the first dose of study medication, intrauterine device or intrauterine system, double-barrier method of contraception (condom and occlusive cap or condom and spermicidal agent), male sterilization and complete sexual abstinence (if acceptable by local authorities). Periodic abstinence is not an acceptable method of contraception.\n* Known allergy to dabigatran, ticagrelor, clopidogrel, aspirin, or to the excipients used for the tables of the drugs;\n* Contraindications, in the Investigator's opinion to dabigatran, ticagrelor, clopidogrel, or aspirin;\n* Participation in another trial with an investigational drug or device within the past 30 days preceding the screening visit (patients participating in an observational study only will not be excluded);\n* Patients who are not willing or able to comply with the protocol requirements or considered unreliable by the Investigator concerning the requirements for follow-up during the study and\u002For compliance with study drug administration, who have a life expectancy less than the expected duration of the trial due to concomitant disease, or who have any condition which in the opinion of the Investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).",{"count":424,"type":21},1194,[101],"More than 25% of patients referred for diagnostic coronary angiography and percutaneous coronary intervention (PCI) due to acute coronary syndrome (ACS) suffer from non-valvular atrial fibrillation (AF). In this particular setting, balancing between the prevention of thrombosis and the risk of bleeding remains challenging. Oral anticoagulation (OAC) prevents stroke and systemic embolism, but has not been shown to prevent stent thrombosis (ST). Dual antiplatelet therapy (DAPT) reduces the incidence of recurrent ischemic events and ST, but is less effective in reducing the incidence of cardioembolic stroke associated with AF. A common guideline-supported practice is to combine three drugs (OAC, aspirin and clopidogrel) in a triple therapy, which is associated with high annual risk (up to 25%) of major bleeding. Thus, new therapeutic strategies are urgently needed to maintain the efficacy while improving the safety of treatment in patients with AF and ACS undergoing PCI.\n\nThis is a prospective, randomized, open-label, blinded-endpoint, non-inferiority trial. 1194 patients with non-valvular AF that had undergone successful PCI due to an ACS within the previous 120 hours will be randomized in 1:1 ratio to receive one of the two treatments: dual therapy with dabigatran (150 mg twice daily or 110 mg twice daily) and ticagrelor (90 mg twice daily for 1 month, followed by 60 mg twice daily up to 12 months), or standard therapy according to current guidelines triple therapy with dabigatran (150 mg b.i.d. or 110 mg b.i.d.) plus clopidogrel (75 mg o.d.) plus aspirin (75 mg o.d.) followed by double therapy depending on the bleeding and ischaemic risk. Study treatment will be continued for 12 months. The primary study end-point is the first major or clinically relevant non-major bleeding event (per ISTH), in a time-to-event analysis. The main secondary end-point is a composite efficacy end-point of thromboembolic events (myocardial infarction, stroke, or systemic embolism), death, or unplanned revascularization (PCI or coronary artery bypass grafting) at 12 months.\n\nWe expect that dual antithrombotic therapy including reduced dose ticagrelor and dabigatran is at least non-inferior regarding bleeding risk and ischaemic protection, compared to the standard triple therapy in patients with AF and after ACS, treated with PCI.",[428,429,27,430],"Atrial Fibrillation","Antithrombotic Therapy","Percutaneous Coronary Interventions",[428,27,432,433,434],"Dabigatran","Ticagrelor","Antithrombotic therapy","2026-06-14",{"date":437,"type":37},"2026-06-16",{"date":439,"type":37},"2021-10-25",{"date":441,"type":21},"2026-08-31",{"name":443,"class":44},"Medical University of Gdansk",{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":452,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":455,"briefSummary":456,"conditions":457,"keywords":461,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":301},"100517174","predictive-value-of-glycemic-parameters-measured-with-the-fsl-pro-iq-during-acs-100517174","NCT06014112","Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ During ACS","Predictive Value of Glycemic Parameters Measured With the Freestyle Libre Pro iQ During Acute Coronary Syndrome","FREESCA","Inclusion Criteria:\n\n* Patients with ACS managed in a cardiac intensive care unit (ICU). The diagnosis of ACS will be made in the presence of chest pain with ST-segment elevation on the ECG for STEMI or ST-segment change and\u002For a positive troponin cycle (values in accordance with the center's protocol) for NSTEMI.\n\nExclusion Criteria:\n\n* Subjects in cardiogenic or septic shock\n* Subjects with ACS initially managed in a non-investigating center\n* Failure to obtain free, informed, written consent signed by the participant and investigator upon admission to the ICU\n* Person participating in another research study with an ongoing exclusion period\n* Subjects participating in a study that may have an impact on post ACS prognosis\n* Person deprived of his or her rights, person under guardianship or curatorship\n* Person deprived of liberty (by judicial or administrative decision)\n* Persons whose physical and\u002For psychological health is severely impaired, which, in the opinion of the investigator, may affect the participant's compliance to the study\n* Pregnant or breastfeeding women\n* Person who is not affiliated to a social security system or who is a beneficiary of such a system.","85 Years",{"count":454,"type":21},850,[160],"Disorders of glycemic regulation are common in patients hospitalized for acute coronary syndrome (ACS). Abnormal glycaemia is observed in 50% of cases, in 30-40% diabetes, and in 25-35% fasting hyperglycaemia or glucose intolerance.\n\nHyperglycemia is a major prognostic factor in ACS, with admission hyperglycemia having independent prognostic value for both short- and long-term major cardiovascular events (MACE), regardless of the presence of diabetes.\n\nMetabolically, several situations can be distinguished:\n\n* Hyperglycaemia occurs in known non-diabetic ACS subjects. It can be indicative of (i) Type 2 Diabetes or (ii) stress hyperglycaemia (diagnostic threshold for blood sugar varies according to learned societies, with HbA1c \\\u003C 6.5%).\n* Hyperglycaemia occurs in known diabetic ACS subjects Most studies use admission blood sugar as a predictor. However, it has recently been shown that glycemic variability indexes would be better predictors of MACE. Using continuous glucose measurement for 48 h, it has been shown that significant glycemic variability is a more powerful predictor of MACE at 1 year than admission glycemia The measurement of glycemic variability is mainly possible thanks to the development of CGM (continuous glucose measurement).\n\nTo our knowledge, no study has been interested in evaluating the predictive value of the various glycemic parameters measured by CGM.\n\nPublished studies have used continuous glucose measurements for very short periods (24 or 72 hours maximum), which limits these measurements.\n\nThe freestyle libre Pro iQ (FSLPro iQ) is a professional sensor for continuous, non-invasive interstitial glucose measurement allowing the recording of glycemic parameters for 2 weeks.\n\nOur hypothesis is that glycaemic parameters, alone or in combination with each other or with other patient risk factors, measured with the Freestyle libre Pro iQ have a significant prognostic value in terms of cardiovascular clinical events at 12 months in a population of patients with ACS managed as standard and followed up.",[27,458,459,460],"Continuous Glucose Measurement","Glycemic Variability","Cardiovascular Event",[29,462,463,464],"continuous glucose measurement","glycemic variability","cardiovascular event",{"date":466,"type":37},"2026-06-12",{"date":468,"type":37},"2023-11-06",{"date":470,"type":21},"2028-05-06",{"name":472,"class":44},"University Hospital, Montpellier",{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":16,"minAge":481,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":22,"phases":483,"briefSummary":484,"conditions":485,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":497},"100475637","phase-3-doxycycline-host-directed-therapy-to-improve-lung-function-and-decrease-tissue-destruction-in-pulmonary-tuberculosis-100475637","NCT05473520","Doxycycline Host-directed Therapy to Improve Lung Function and Decrease Tissue Destruction in Pulmonary Tuberculosis","Doxycycline Host-directed Therapy to Improve Lung Function and Decrease Tissue Destruction in Pulmonary Tuberculosis: A Phase III Randomized Control Trial (Doxy-TB)","Doxy-TB","The recruitment target would be 150 patients, with 75 in each arm\n\nInclusion criteria: Patients should meet all criteria:\n\n1. Aged 21 years and above\n2. Patients receiving ≤ 14 days of TB treatment or about to start standard combination TB treatment\n3. Confirmed pulmonary TB with positive acid-fast bacilli smear and\u002For positive nucleic acid amplification test (NAAT) and\u002For TB culture results\n4. CXR demonstrating pulmonary involvement with cavity or cavities\n5. Able to provide informed consent\n\nExclusion criteria:\n\n1. HIV co-infection\n2. Previous pulmonary TB\n3. Severe, pre-existing lung disease such as pulmonary fibrosis, bronchiectasis, COPD and lung cancer\n4. Pregnant or breast feeding\n5. Allergies to tetracyclines\n6. Patients on retinoic acid, neuromuscular blocking agents and pimozide which may increase risk of drug toxicity\n7. Autoimmune disease and\u002For on systemic immunosuppressants\n8. Use of any investigational or non-registered drug, vaccine or medical device other than the study drug within 182 days preceding dosing of study drug, or planned use during the study period\n9. Enrolment in any other clinical trial involving a systemic drug or intervention involving the lung\n10. Evidence of severe depression, schizophrenia or mania\n11. ALT \\> 3 times upper limit of normal\n12. Creatinine \\> 2 times upper limit of normal\n13. Principal investigator assessment of lack of willingness to participate and comply with all requirements including follow-up of the protocol, or identification of any factor felt to significantly increase the participant's risk of suffering an adverse outcome","21 Years",{"count":54,"type":21},[129],"Tuberculosis (TB) is a global pandemic that despite successful treatment and bacterial eradication can cause chronic ill health, such as pulmonary impairment after tuberculosis (PIAT) and cardiovascular disease (CVD). A recent Phase 2b double-blind randomised-controlled clinical trial shows that adjunctive doxycycline therapy is safe, accelerates resolution of inflammation, suppresses tissue damaging enzyme activity and decreases pulmonary cavity volume (1). We aim to determine if adjunctive doxycycline can reduce PIAT and improve cardiovascular outcomes in a fully powered Phase III trial of 8 weeks of adjunctive doxycycline alongside standard pulmonary TB (PTB) treatment.\n\nThe investigators hypothesize that doxycycline inhibits tissue destruction in patients with PTB and thereby leads to improved lung function after treatment.\n\nSpecific aims\n\n1. To assess improvement in lung function as measured by forced expiratory volume (FEV1) predicted in PTB patients given doxycycline versus placebo.\n2. To investigate whether doxycycline will hasten the resolution of pulmonary cavities measured by CT thorax\n3. To investigate whether doxycycline can suppress inflammatory markers including matrix metalloproteinases\n4. To investigate whether doxycycline can accelerate time to sputum conversion\n5. To evaluate the effect of doxycycline on cardiovascular outcomes such as the incidence of acute coronary syndrome (ACS) and pulmonary hypertension\n6. To investigate whether doxycycline improves TB drug concentrations in sputum and plasma.\n7. To assess the safety profile of doxycycline with concurrent standard anti-tuberculous treatment.",[486,27,487],"Tuberculosis","Pulmonary Hypertension (Diagnosis)","2026-06-08",{"date":490,"type":37},"2026-06-09",{"date":492,"type":37},"2023-05-24",{"date":494,"type":21},"2030-01-31",{"name":496,"class":44},"National University Hospital, Singapore",6,{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":506,"targetDuration":507,"studyType":55,"phases":4,"briefSummary":508,"conditions":509,"keywords":511,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":89},"100636249","polymer-free-sirolimus-eluting-stent-real-world-investigation-of-safety-and-outcomes-100636249","NCT07563231","Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes","POLARIS : POLymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes","POLARIS","Inclusion Criteria:\n\n* Age \\>= 18 years at the time of the index procedure.\n* Percutaneous coronary intervention performed at Geneva University Hospitals between January 2021 and December 2025.\n* Implantation of at least one study device\n* Indication for PCI according to current European or American guidelines.\n* Able and willing to provide written informed consent.\n* Sufficient knowledge of French, German, English, or Italian to understand the patient information document.\n\nExclusion Criteria:\n\n* Documented refusal to participate in research through opt-out from general consent.\n* Inability to provide informed consent (cognitive impairment or other).\n* Inability to be contacted for informed consent (no valid contact information, or unreachable after three contact attempts).\n* Life expectancy less than 12 months due to non-cardiac comorbidities at the time of consent.\n* Participation in another clinical trial that would interfere with the endpoints of this registry.",{"count":127,"type":21},"5 Years","POLARIS is a prospective, single-centre, single-arm observational pilot registry evaluating the real-world safety and efficacy of the Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) polymer-free sirolimus-eluting stent in consecutive adult patients undergoing percutaneous coronary intervention (PCI). The primary endpoint is target lesion failure (TLF) at 12 months, defined per Academic Research Consortium-2 (ARC-2) criteria as the device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. Patients treated since January 2021 will be retrospectively identified and prospectively consented, with follow-up through 5 years. The registry will provide the first Western clinical evidence on this CE-marked device and serve as a template for a future national Swiss multicentre registry.",[104,27,339,510,105],"Stent Thrombosis",[512,513,514,515,516,517,518],"drug-eluting stent","polymer-free stent","sirolimus","percutaneous coronary intervention","target lesion failure","registry","real-world evidence","2026-06-05",{"date":490,"type":37},{"date":522,"type":21},"2026-06",{"date":524,"type":21},"2036-06",{"name":526,"class":44},"Dorian Garin",{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":16,"minAge":534,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":22,"phases":537,"briefSummary":538,"conditions":539,"keywords":542,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":89},"100640379","in-hospital-wearable-based-monitoring-versus-standard-care-in-cardiovascular-disease-inspire-100640379","NCT07622485","In-Hospital Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease (INSPIRE)","In-Hospital Efficacy and Safety of Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease: A Stepped-Wedge Cluster Randomized Controlled Trial (INSPIRE Trial)","Inclusion Criteria:\n\nAdults aged 20 years or older\n\n* Hospitalized for cardiovascular disease, with at least one of: acute coronary syndrome; chronic coronary syndrome; acute heart failure (NYHA class III-IV or acute decompensated heart failure); arrhythmia (atrial fibrillation, ventricular tachycardia, complete AV block, or other clinically significant arrhythmia); peripheral arterial or aortic disease; post-cardiovascular-procedure observation (PCI, CABG, valve surgery, or electrophysiology study); or thromboembolic disease\n* Able to provide written informed consent\n* Able to wear the wearable monitoring device\n\nExclusion Criteria:\n\n* Hemodynamically unstable shock (sustained systolic blood pressure \\\u003C 90 mmHg requiring vasopressors; cardiogenic shock; septic shock)\n* Planned or current intensive care unit admission\n* Within 24 hours after cardiopulmonary resuscitation\n* Physical condition precluding device wearing (bilateral upper-limb amputation; severe skin lesion, burn, or open wound at the device site; known allergy to device materials)\n* Severe cognitive impairment or delirium precluding informed consent Extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP) in use\n* Continuous renal replacement therapy (CRRT) in use (patients on CRRT may participate if hemodynamically stable and device wearing is technically feasible)\n* Unable to communicate in Korean for study explanation and the consent process\n* Previously enrolled in this study (re-admitted patients are not re-enrolled; each participant is enrolled only at the first admission)\n* Considered inappropriate for participation by the investigator","20 Years",{"count":536,"type":21},1500,[160],"Patients hospitalized with cardiovascular disease require timely detection of clinical deterioration to prevent adverse outcomes. Standard inpatient care relies on intermittent nursing vital-sign measurements performed every 4 to 8 hours, which can miss hemodynamic or arrhythmic events occurring between measurements. This trial evaluates whether digital wearable-based monitoring - wireless continuous measurement of vital signs and electrocardiography with a real-time alerting system - reduces major adverse cardiovascular events (MACE) compared with standard intermittent monitoring in patients hospitalized for cardiovascular disease. The trial uses a stepped-wedge cluster-randomized design in which four inpatient ward zones (clusters) are sequentially transitioned from standard care to wearable monitoring over five periods.",[165,27,204,540,541],"Cardiac Arrhythmia","Peripheral Arterial Disease",[543,544,545,546,547,548,549],"wearable device","continuous monitoring","remote monitoring","stepped-wedge cluster trial","major adverse cardiovascular events","digital health","inpatient monitoring","2026-06-01",{"date":552,"type":37},"2026-06-03",{"date":554,"type":21},"2026-07-01",{"date":556,"type":21},"2029-12-31",{"name":558,"class":44},"Yonsei University",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":22,"phases":568,"briefSummary":569,"conditions":570,"keywords":574,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":190},"100638293","feasibility-study-of-a-digital-interactive-life-style-platform-for-individuals-after-rehabilitation-100638293","NCT07597031","Feasibility Study of a Digital Interactive Life-style Platform for Individuals After Rehabilitation","Feas Platf","Inclusion Criteria:\n\n* Adults (≥18 years)\n* 10 or less days before discharge from inpatient rehabilitation at the Bern Rehab Center in Heiligenschwendi or the Insel Hospital (both belonging to the Insel Group)\n* Belonging to one of the following clinical cohorts: acute coronary syndrome or ischemic heart failure; chronic obstructive pulmonary disease (COPD) - clinically diagnosed and confirmed by pulmonary specialist; fragility fracture - e.g., hip fracture or other low-energy fractures; minor stroke, clinically confirmed ischemic or hemorrhagic stroke with mild neurological deficits.\n* Able to provide informed consent.\n* Access to and ability to use a device that has internet access (e.g., tablet, smartphone, laptop, etc.).\n\nExclusion Criteria:\n\n* Cognitive or psychiatric condition interfering with consent or use of the app.\n* Physical disability preventing digital device use without support.\n* Heavy language production or comprehension impairments.",{"count":567,"type":21},240,[160],"The goal of this clinical trial is to evaluate the feasibility and usability of a digital lifestyle platform designed to support patients after discharge from inpatient rehabilitation. It will also assess patient engagement and the potential of the platform to support long-term self-management and healthy lifestyle behaviors in an outpatient setting.\n\nThe main questions it aims to answer are:\n\nIs the platform feasible and acceptable for patients after rehabilitation? Do patients engage with and regularly use the platform over time? Can personalized digital recommendations support adherence to healthy behaviors and self-management?\n\nResearchers will evaluate a telemedicine platform that delivers individualized suggestions, including lifestyle applications, educational content, and advice from healthcare professionals. The content is tailored to patient needs and continuously adapted based on patient feedback.\n\nParticipants will:\n\nUse the digital platform after discharge from inpatient rehabilitation for a defined follow-up period Receive personalized recommendations through the platform Rate the usefulness of recommendations to enable continuous adaptation Attend study visits or remote assessments to evaluate usability, engagement, and outcomes Continue standard outpatient care alongside the intervention",[571,27,572,573],"Chronic Obstructive Pulmonary Disease (COPD)","Fragility Fracture","Minor Stroke",[575,576,577],"Telemedicine","Phase III rehabilitation","Long-term non-communicable diseases","2026-05-18",{"date":580,"type":37},"2026-05-19",{"date":582,"type":21},"2026-05-01",{"date":584,"type":21},"2027-02-01",{"name":586,"class":44},"Matthias Wilhelm, MD",{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":593,"eligibilityCriteria":594,"healthyVolunteers":368,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":597,"conditions":598,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":89},"100523107","florbetaben-for-imaging-of-vascular-amyloid-100523107","NCT06091319","Florbetaben for Imaging of Vascular Amyloid","Florbetaben for Imaging of Vascular Amyloid: Evaluation of Amyloid Inflammasome Imaging in Carotid and Coronary Arteries in Patients With Unstable Atherosclerosis- A Pilot Study","FERMATA","Inclusion Criteria:\n\n1. suffered a recent cardiovascular event (30-120 days post ACS (i.e. STEMI or NSTEMI) or TIA\u002Fstroke with ipsilateral large vessel atherosclerotic disease confirmed on US, CT or MRI;\n2. stable symptoms and hemodynamics;\n3. age \\>\u002F= 18 years;\n4. given informed consent.\n\nExclusion Criteria:\n\n1. a recent CV event likely to have been embolic in the opinion of the neurologist or cardiologist;\n2. severe LV dysfunction (EF\\\u003C30%);\n3. severe valve disease requiring intervention;\n4. decompensated heart failure;\n5. pregnancy (all women of child bearing potential will have a negative BHCG test;\n6. breastfeeding;\n7. women of childbearing potential who refuse to use two forms of contraception (this includes at least one form of highly effective and one effective method of contraception) throughout the study OR men capable of fathering a child who refuse to use contraception;.\n8. unable to give informed consent;.\n9. Florbetaben allergy;\n10. glomerular filtration rate (GFR) \\\u003C50 ml\u002Fmin\u002F1.72m2\n\nExclusion for CTA portion of the protocol: Patients with dye allergy, or those with GFR \\\u003C60, will not undergo CTA but will have PET\u002FCT.",{"count":596,"type":21},30,"The Primary Objective is to determine if a new nuclear tracer (named 18F-Florbetaben) used with nuclear imaging (PET imaging) can detect inflamed plaque in patients with recent ACS or stroke\u002FTIA.",[27,599,600,601],"Stroke","Transient Ischemic Attack","Atherosclerosis of Artery","2026-05-05",{"date":604,"type":37},"2026-05-08",{"date":606,"type":37},"2023-10-09",{"date":608,"type":21},"2026-08-01",{"name":610,"class":44},"Ottawa Heart Institute Research Corporation",{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":617,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":16,"minAge":333,"maxAge":4,"enrollmentInfo":619,"targetDuration":4,"studyType":22,"phases":621,"briefSummary":622,"conditions":623,"keywords":625,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":635,"locationsCount":637},"100618290","artificial-intelligence-driven-medipixel-fractional-flow-reserve-versus-invasive-fractional-flow-reserve-guided-pci-trial-aim-ffr-trial-100618290","NCT07329699","Artificial Intelligence-Driven Medipixel Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI Trial (AIM-FFR Trial)","Artificial Intelligence-Driven Angiography-Based Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI","AIM-FFR","Inclusion Criteria:\n\n1. Subject must be at least 19 years of age\n2. Eligible for coronary angiography and\u002For percutaneous coronary intervention.\n3. Chronic coronary syndrome or acute coronary syndrome (non-culprit vessels only)\n4. Coronary artery disease in one or more native major epicardial vessels or their branches with reference vessel diameter of at least 2.5mm and with visually assessed coronary stenosis in which the physiological severity of the lesion is questionable (typically 40-90% diameter stenosis).\n5. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.\n\nExclusion Criteria:\n\n1. Patients unable to provide informed consent\n2. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents and drug-coated balloons\n3. Patients with coronary artery bypass grafting\n4. Patients who have non-cardiac co-morbid conditions with life expectancy \\\u003C1 year\n5. Patients with cardiogenic shock or cardiac arrest\n6. Patients with severe left ventricular systolic dysfunction (ejection fraction \\\u003C30%)\n7. Patients with severe valvular heart disease requiring open heart surgery\n8. Pregnant or lactating women\n9. Angiographic exclusion criteria\n\n   * Culprit vessel of patients with ST-elevation myocardial infarction (target lesions in non-culprit vessel can be enrolled)\n   * Chronic total occlusion (target lesions in vessels without chronic total occlusion can be enrolled)\n   * Ostial stenosis in left man coronary artery or right coronary artery\n   * Severe tortuosity of any target vessel\n   * Severe overlap in the stenosed segment\n   * Poor image quality precluding identification of vessel contours",{"count":620,"type":21},2100,[160],"The AIM-FFR trial is a prospective, multi-center, open-label, randomized controlled, non-inferiority trial. The current trial will evaluate non-inferiority of MPFFR-guided PCI, compared with invasive FFR-guided PCI in patients with coronary artery disease.",[104,624,27],"Chronic Coronary Syndrome",[626,627,628],"Coronary artery stenosis","Fractional flow reserve","Prognosis","2026-04-21",{"date":631,"type":37},"2026-04-23",{"date":633,"type":37},"2026-03-18",{"date":556,"type":21},{"name":636,"class":44},"Samsung Medical Center",23,{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":642,"acronym":4,"eligibilityCriteria":643,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":644,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":646,"conditions":647,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":651,"completionDateStruct":653,"leadSponsor":655,"locationsCount":4},"100635316","relationship-between-inflammatory-hs-crp-neutrophil-to-lymphocyte-ratio-and-cardiac-troponin-biomarkers-and-cardiac-dysfunction-in-acute-coronary-syndrome-100635316","NCT07551102","Relationship Between Inflammatory (Hs-CRP, Neutrophil-to-Lymphocyte Ratio) and Cardiac (Troponin) Biomarkers, and Cardiac Dysfunction in Acute Coronary Syndrome.","Inclusion Criteria:\n\n* • Adult patients (≥18 years)\n\n  * Patients diagnosed with Acute Coronary Syndrome (STEMI, NSTEMI, or unstable angina)\n  * Presentation within 24 hours of symptoms onset\n  * Informed consent\n\nExclusion Criteria:\n\n* • Chronic inflammatory diseases\n\n  * Active infection\n  * Malignancy\n  * Severe hepatic or renal failure\n  * Autoimmune diseases\n  * Patients with known cardiomyopathy or chronic reduced ejection fraction\n  * Patients with ACS treated with thrombolysis",{"count":645,"type":21},144,"Acute Coronary Syndrome (ACS) remains a leading cause of morbidity and mortality worldwide, accounting for a significant proportion of cardiovascular-related deaths. Early diagnosis and accurate risk stratification are crucial for improving clinical outcomes and guiding therapeutic decisions. Cardiac troponins (I and T) are highly sensitive and specific biomarkers of myocardial injury and represent the gold standard for the diagnosis of ACS (1).\n\nIn recent years, inflammation has been recognized as a key contributor to the pathophysiology of atherosclerosis and plaque instability. Inflammatory biomarkers such as high-sensitivity C-reactive protein (hs-CRP) and the neutrophil-to-lymphocyte ratio (NLR) have gained attention as predictors of adverse cardiovascular outcomes. Elevated hs-CRP levels are associated with increased risk of myocardial infarction and poor prognosis (2), while NLR reflects the balance between inflammatory activation and immune regulation and has been linked to severity of coronary artery disease and mortality in ACS patients (3).\n\nEchocardiography remains a cornerstone in the assessment of cardiac function, providing essential information about left ventricular ejection fraction (LVEF) and regional wall motion abnormalities (RWMA). More recently, speckle tracking echocardiography (STE) has emerged as a sensitive tool for detecting subclinical myocardial dysfunction through parameters such as global longitudinal strain (GLS), even before a reduction in LVEF becomes apparent (4,5).\n\nDespite the established individual roles of cardiac and inflammatory biomarkers, limited data are available regarding their combined effect on cardiac function, particularly when integrated with advanced echocardiographic techniques. Therefore, this study aims to evaluate the relationship between inflammatory biomarkers (hs-CRP, NLR), cardiac biomarker (troponin), and echocardiographic findings in patients with ACS to enhance early risk stratification and improve clinical decision-making.",[27],"2026-04-19",{"date":650,"type":37},"2026-04-24",{"date":652,"type":21},"2026-05",{"date":654,"type":21},"2026-12",{"name":656,"class":44},"Assiut University",{"id":658,"slug":659,"hasResults":12,"nctId":660,"briefTitle":661,"officialTitle":662,"acronym":663,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":665,"enrollmentInfo":666,"targetDuration":4,"studyType":22,"phases":668,"briefSummary":669,"conditions":670,"keywords":672,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":89},"100470976","positive-emotions-following-acute-cardiac-events-100470976","NCT05412862","Positive Emotions Following Acute Cardiac Events","A Novel Psychological-behavioral Intervention to Promote Physical Activity After Acute Coronary Syndrome","PEACE-V","Inclusion Criteria:\n\n* ACS (myocardial infarction or unstable angina)\n* Suboptimal physical activity (score of \\\u003C 6 on the Medical Outcomes study Specific Adherence Scale item related to physical activity)\n\nExclusion Criteria:\n\n* Cognitive deficits (assessed via a 6-item cognitive screening tool)\n* Medical conditions likely to lead to death within 6 months.\n* Moderate-severe depression (Patient Health Questionnaire-9 \\[PHQ-9\\] score ≥15)\n* Inability to participate in physical activity due to another medical condition (e.g., arthritis)\n* Inability to read, write, or speak in English\n* Inability to receive text-messages\n* Current participation in another intervention or program that has been designed to promote well-being or physical activity","95 Years",{"count":667,"type":21},280,[160],"The focus of this study is to test the efficacy of a 12-week, remotely delivered, positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice weekly text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks), compared to post-acute coronary syndrome (ACS) treatment as usual, in a randomized trial of 280 post-ACS patients with low baseline physical activity.",[27,671],"Physical Inactivity",[673,674,675,241],"Positive psychology","Physical Activity","Motivational Interviewing","2026-04-15",{"date":678,"type":37},"2026-04-20",{"date":680,"type":37},"2022-09-12",{"date":682,"type":21},"2028-03-31",{"name":684,"class":44},"Massachusetts General Hospital",{"id":686,"slug":687,"hasResults":12,"nctId":688,"briefTitle":689,"officialTitle":689,"acronym":4,"eligibilityCriteria":690,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":691,"targetDuration":4,"studyType":22,"phases":693,"briefSummary":694,"conditions":695,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":697,"lastUpdatePostDateStruct":698,"startDateStruct":700,"completionDateStruct":702,"leadSponsor":704,"locationsCount":89},"100610689","a-study-evaluating-the-vascular-healing-and-neointimal-transformation-at-1-month-after-implantation-of-biofreedom-drug-coated-stents-and-the-xience-drug-eluting-stent-system-in-patients-with-acute-coronary-syndrome-and-high-bleeding-risk-using-optical-coherence-tomography-100610689","NCT07230847","A Study Evaluating the Vascular Healing and Neointimal Transformation at 1 Month After Implantation of BioFreedom™ Drug-coated Stents and the Xience Drug-eluting Stent System in Patients With Acute Coronary Syndrome and High Bleeding Risk Using Optical Coherence Tomography","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Male or non-pregnant female\n3. Acute coronary syndrome (ACS) patients requiring percutaneous coronary intervention (PCI)\n4. No contraindications for coronary artery bypass grafting (CABG)\n5. High bleeding risk (HBR) patients per ARC-HBR definition (meeting ≥1 major or 2 minor criteria):\n\n   Major Criteria:\n   * Expected long-term oral anticoagulation\n   * Severe\u002Fend-stage chronic kidney disease (eGFR \\\u003C30 mL\u002Fmin)\n   * Moderate\u002Fsevere anemia (Hb \\\u003C110 g\u002FL)\n   * Spontaneous bleeding requiring hospitalization\u002Ftransfusion within 6 months (or recurrent)\n   * Chronic bleeding diathesis\n   * Moderate\u002Fsevere thrombocytopenia pre-PCI (platelet count \\\u003C100×10⁹\u002FL)\n   * Liver cirrhosis with portal hypertension\n   * Active malignancy in past 12 months (excluding non-melanoma skin cancer; defined as diagnosis\u002Ftreatment within 12 months)\n   * History of spontaneous intracranial hemorrhage\n   * Traumatic intracranial hemorrhage within 12 months\n   * Known cerebral arteriovenous malformation\n   * Moderate\u002Fsevere ischemic stroke within 6 months\n   * Major surgery\u002Fsevere trauma within 30 days pre-PCI\n   * Planned non-deferrable major surgery during dual antiplatelet therapy\n\n   Minor Criteria:\n   * Age ≥75 years\n   * Moderate chronic kidney disease (eGFR:30\\~59 ml\u002Fmin)\n   * Mild anemia (male: Hb=110\\~129 g\u002FL; female: Hb=110\\~119 g\u002FL)\n   * Spontaneous bleeding requiring hospitalization\u002Ftransfusion within 6-12 months pre-PCI\n   * Chronic NSAID\u002Fsteroid use post-PCI\n   * Ischemic stroke \\>6 months pre-PCI\n6. Capable of understanding trial objectives and providing informed consent\n\nAngiographic Inclusion Criteria:\n\n1. Target lesion must be primary native coronary artery lesion\n2. Target lesion with ≥70% diameter stenosis (visual estimate), or 50-70% diameter stenosis (visual estimate) with ischemic evidence\n3. ≥1 non-target lesion requiring intervention\n4. Non-target lesions eligible for elective treatment within 1 month\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria:\n\n1. Presence of ≥1 evidence of heart failure including:\n\n   * NYHA Class III or higher, or\n   * Killip classification ≥ Grade 2, or\n   * Left ventricular ejection fraction (LVEF) ≤30% within 30 days pre-procedure (by echocardiography or intraoperative ventriculography)\n2. Cardiogenic shock patients\n3. Known allergies to: Aspirin \u002F clopidogrel \u002F ticagrelor \u002F heparin, Contrast agents\u002Fdrugs used in drug-eluting stents or contraindications to aspirin\u002F clopidogrel \u002F ticagrelor\n4. Life expectancy \\\u003C12 months or factors potentially compromising clinical follow-up\n5. Participation in other drug\u002Fmedical device trials prior to enrollment without reaching primary endpoint timelines\n6. History of substance abuse (alcohol\u002Fcocaine\u002Fheroin, etc.)\n7. Severe arrhythmias (e.g., high-risk ventricular premature contractions\u002F ventricular tachycardia)\n8. Other medical conditions deemed unsuitable by investigators\n\nAngiographic Exclusion Criteria:\n\n1. Left main coronary artery disease\n2. Bypass graft lesions\n3. Evidence of extensive thrombus in target vessel",{"count":692,"type":21},60,[160],"BioFreedom™ is the world's first polymer-free drug-coated stent (DCS), utilizing a proprietary microstructured surface technology. Its abluminal microporous surface directly carries BA9™ (a sirolimus derivative) with high lipophilicity. This design mitigates inflammatory responses while promoting early vascular healing and reducing thrombotic risk. Extensive clinical evidence has validated BioFreedom™'s superior performance in high-bleeding-risk (HBR) populations. However, comprehensive assessments of neointimal coverage and quantitative neointimal transformation post-implantation remain insufficient. With advancements in ultra-high-resolution optical coherence tomography (OCT), detailed evaluation of coronary stent healing has become feasible. This study will employ OCT to comparatively assess vascular healing patterns-including neointimal transformation and strut coverage-in ACS patients with HBR receiving either the commercially available BioFreedom™ DCS or Xience drug-eluting stent system. The findings will provide multidimensional insights into the devices' post-implantation efficacy and safety profiles.",[696,27],"Coronary Heart Disease","2026-03-31",{"date":699,"type":37},"2026-04-06",{"date":701,"type":37},"2025-12-10",{"date":703,"type":21},"2027-03-31",{"name":118,"class":88},{"id":706,"slug":707,"hasResults":12,"nctId":708,"briefTitle":709,"officialTitle":710,"acronym":711,"eligibilityCriteria":712,"healthyVolunteers":12,"sex":713,"minAge":17,"maxAge":309,"enrollmentInfo":714,"targetDuration":716,"studyType":55,"phases":4,"briefSummary":717,"conditions":718,"keywords":721,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":728,"lastUpdatePostDateStruct":729,"startDateStruct":731,"completionDateStruct":733,"leadSponsor":735,"locationsCount":737},"100550044","prospective-multicenter-registry-of-gender-diversity-and-inclusion-gedi-of-women-with-acute-coronary-syndrome-100550044","NCT06441942","Prospective Multicenter Registry of Gender, Diversity and Inclusion (GEDI) of Women With Acute Coronary Syndrome","Creation of a Prospective Multicenter Registry of Gender, Diversity and Inclusion (GEDI) in Phenotypic and Genetic Characterization of Acute Coronary Syndrome.","ACS GEDI","Inclusion Criteria:\n\n* Women \\>\u002F= 18 years with ACS (STEMI, NSTEMI or Unstable Angina).\n\nExclusion Criteria:\n\n* age \\\u003C 18 years and\u002For unwillingness to sign informed consent and\u002For unwillingness to make follow-up visits","FEMALE",{"count":715,"type":21},100,"12 Months","Create a multicenter prospective registry that collects information from women affected by acute coronary syndrome (ACS). This registry aims to understand the diversity in the presentation of women with ACS. It proposes to conduct a thorough characterization of the women involved in the study through genetic, biochemical, and molecular analysis.This approach aims to identify any differences in the characteristics of women with ACS and to identify disease subtypes that may influence treatment options and clinical outcomes.",[27,719,720],"Gender","Genetic Predisposition",[66,722,723,724,725,726,727],"GEDI","Genetic","DNA","mRNA","Proteomic","Metabolomic","2026-03-30",{"date":730,"type":37},"2026-04-03",{"date":732,"type":37},"2025-01-28",{"date":734,"type":21},"2027-02-28",{"name":736,"class":44},"IRCCS San Raffaele",4]