[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Leipzig Heart Science gGmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":225},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,56,87,114,144,171,200],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100651657","routine-microaxial-heart-pump-support-and-protocolized-pulmonary-artery-catheter-monitoring-versus-standard-care-in-heart-attack-related-cardiogenic-shock-100651657",false,"NCT07762560","Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic Shock","Routine Microaxial Flow Pump Versus Radial Access Revascularization Without Routine Microaxial Flow Pump in Infarct-Related Cardiogenic Shock & Routine Pulmonary Artery Catheterization-based Monitoring With Protocolized Hemodynamic Optimization Versus Simplified Monitoring Without Protocolized Hemodynamic Optimization in Infarct-Related Cardiogenic Shock","DOUBLE-SHOCK","Inclusion Criteria:\n\nCardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory all 4 of these:\n\n1. Planned immediate angiography and revascularization (preferred PCI)\n2. Systolic blood pressure \\\u003C100 mmHg or catecholamines required to maintain pressure \\>90 mmHg during systole\n3. Arterial lactate \\>2.0 mmol\u002FL\n4. Echocardiogram with LVEF \\\u003C40% or left ventricular outflow tract velocity time integral (LVOT-VTI) ≤12 cm\n\nExclusion Criteria:\n\n1. Age \\\u003C18 and \\>80 years\n2. Shock duration \\>12 hours\n3. Other causes of shock (hypovolemia, sepsis, pulmonary embolism or anaphylaxis).\n4. Shock due to mechanical complication of AMI\n5. Witnessed out-of-hospital cardiac arrest (OHCA) with chest compression \\>10 min in total (cardiac arrest occurring in ambulance or after hospital arrival is NOT an exclusion criterion and witnessed OHCA with duration of chest compression \\\u003C10 min are also eligible)\n6. After 390 included patients with OHCA, any OHCA will be an exclusion criterion\n7. Any unwitnessed OHCA\n8. Refractory cardiac arrest with ongoing chest compression\n9. Evidence of severe right ventricular failure\n10. Severe aorta valve regurgitation\u002Fstenosis\n11. Severe peripheral arterial obstructive disease precluding mAFP placement\n12. Abnormalities of the aorta precluding mAFP device placement\n13. Presence of a mechanical aortic valve prosthesis\n14. Left ventricular thrombus\n15. Infective endocarditis\n16. Life expectancy \\\u003C1 year due to comorbidities\n17. Mental disorder or language barrier that preclude informed consent\n18. Known pregnancy","ALL","18 Years","80 Years",{"count":21,"type":22},780,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn which treatment strategies improve survival in adult patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS).\n\nThe main questions it aims to answer are:\n\n* Does the immediate use of a left-sided microaxial flow pump (Impella) after percutaneous coronary intervention (PCI) improve survival compared to initial medical therapy alone?\n* Does protocol-based hemodynamic monitoring and optimization using a pulmonary artery catheter (PAC) improve survival compared to conventional intensive care monitoring?\n\nResearchers will compare four treatment combinations to see if mechanical circulatory support and\u002For advanced hemodynamic monitoring reduce mortality in AMI-CS patients:\n\n* Microaxial flow pump + pulmonary artery catheter\n* Microaxial flow pump + conventional monitoring\n* Medical therapy alone + pulmonary artery catheter\n* Medical therapy alone + conventional monitoring\n\nParticipants will:\n\n* Undergo immediate coronary angiography and PCI upon hospital admission Be randomly assigned to one of four treatment groups\n* Receive either immediate implantation of a microaxial flow pump or initial medical therapy with vasoactive agents following PCI\n* Be monitored either via pulmonary artery catheter with protocol-based hemodynamic optimization or via conventional intensive care monitoring\n* Be followed up at 30 days, 6 months and 12 monthsafter Randomization, with planned annual follow-up assessments for up to 10 years",[28,29,30],"Cardiogenic Shock","Acute Myocardial Infarction (AMI)","Heart Failure, Acute",[32,33,34,35,36,37,38,39,40,41,42],"2x2 factorial design","Mortality","Intensive care","Percutaneous coronary intervention","Hemodynamic monitoring","Mechanical circulatory support","Impella","Microaxial flow pump","AMI-CS","Acute myocardial infarction","Cardiogenic shock","NOT_YET_RECRUITING","2026-08-07",{"date":46,"type":47},"2026-08-13","ACTUAL",{"date":49,"type":22},"2026-10-01",{"date":51,"type":22},"2037-04",{"name":53,"class":54},"Leipzig Heart Science gGmbH","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":67,"conditions":68,"keywords":69,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":55},"100646673","crp-apheresis-in-infarct-related-cardiogenic-shock-100646673","NCT07687017","CRP Apheresis in Infarct-Related Cardiogenic Shock","Selective C-Reactive Protein Apheresis in Cardiogenic Shock Complicating Acute Myocardial Infarction (CRP-SHOCK Trial)","CRP-SHOCK","Inclusion Criteria:\n\n* Cardiogenic shock complicating acute myocardial infarction with planned revascularization by percutaneous coronary intervention (PCI).\n* Cardiogenic shock defined as:\n* Systolic blood pressure \\\u003C90 mmHg for \\>30 minutes or requirement of catecholamine infusion to maintain systolic blood pressure ≥90 mmHg, and\n* Signs of impaired organ perfusion (at least one of the following): Cold, clammy skin and extremities, Altered mental status, Oliguria with urine output \\\u003C30 mL\u002Fhour, Arterial lactate \\>2 mmol\u002FL\n* C-reactive protein (CRP) level ≥7 mg\u002FL at baseline.\n* Age ≥18 years.\n* Informed consent provided by the participant or, if the participant is unable to consent, inclusion after assessment and documentation of the presumed patient's will by two physicians (one independent), with informed consent obtained as soon as possible.\n\nExclusion Criteria:\n\n* Fever (body temperature \\>38°C) or acute infection with fever within the last 14 days.\n* Chronic inflammatory disease.\n* Known history of severe hepatic failure.\n* Chronic kidney disease with creatinine clearance \\\u003C30 mL\u002Fmin\u002F1.73 m² prior to hospital admission.\n* Life expectancy \\\u003C12 months prior to cardiogenic shock.\n* Participation in another interventional clinical trial.\n* Pregnancy.\n* Resuscitation duration \\>30 minutes.\n* Cardiogenic shock due to causes other than acute myocardial infarction.\n* Onset of cardiogenic shock \\>12 hours before randomization.\n* Age \\>80 years.",{"count":65,"type":22},50,[25],"Cardiogenic shock complicating acute myocardial infarction remains associated with high short-term mortality despite guideline-directed therapy. Systemic inflammation, particularly elevated C-reactive protein (CRP), may contribute to ongoing myocardial injury and organ dysfunction.\n\nThe CRP-SHOCK trial is an investigator-initiated, prospective, randomized, open-label, multicenter pilot study evaluating selective CRP apheresis as an adjunct to standard of care in patients with infarct-related cardiogenic shock. Patients are randomized to receive either standard therapy alone or standard therapy plus selective CRP apheresis using the PentraSorb®-CRP system.\n\nThe primary objective is to assess the effect of CRP apheresis on the CLIP score at 66 ± 8 hours after randomization. Secondary objectives include clinical outcomes, inflammatory biomarkers, and safety endpoints.",[28,29],[70,71,72,73,74,41,75,76,77,78],"C-reactive protein","CRP apheresis","Selective CRP apheresis","Inflammation","Infarct-related cardiogenic shock","CLIP score","PentraSorb-CRP","Pilot study","Multicenter study","2026-07-03",{"date":81,"type":47},"2026-07-07",{"date":83,"type":22},"2026-07-20",{"date":85,"type":22},"2027-10-31",{"name":53,"class":54},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100567737","early-catheter-directed-treatment-of-high-risk-pulmonary-embolism-100567737","NCT06672081","Early Catheter-directed Treatment of High Risk Pulmonary Embolism","A Randomized Trial for Early Catheter-directed Treatment of High Risk Pulmonary Embolism","CATCH-PE II","Inclusion Criteria:\n\n1. Pulmonary embolism as confirmed by CT angiogram with high mortality risk as defined by ESC guidelines:\n\n   a) One of the following: i. Cardiac arrest or ii. obstructive shock (systolic BP \\\u003C90 mmHg or vasopressors required to achieve a BP ≥90 mmHg despite an adequate filling status), in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol\u002FL) and b) Signs of right-ventricular dysfunction on transthoracic echocardiogram or CT scan\n2. Age ≥18 years\n\nExclusion Criteria:\n\n1. Contraindications for catheter-based treatment\n2. Contraindications to systemic fibrinolytic treatment or anticoagulation\\*\n\n   1. Active, potentially life-threatening bleeding\n   2. Surgery within 24h before screening\n   3. Cranial or spinal surgery within 14d before screening\n   4. Stroke within 14d before screening\n   5. Intracranial tumor\n   6. Any condition not listed here but estimated as clinically relevant as judged by the treating investigator\n3. Pregnancy\n\n   * Patients with contraindications to systemic fibrinolysis or anticoagulation can be enrolled in a third study arm (registry) and undergo catheter-directed therapy.",{"count":96,"type":22},210,[25],"Prospective, multicenter, open label, randomized controlled clinical trial to compare the effects of an early catheter-directed treatment plus conventional care with conventional care in patients with high-risk pulmonary embolism",[100],"Pulmonary Embolism Acute Massive",[102,103],"pulmonary embolism","early catheter-directed treatment","RECRUITING","2026-03-03",{"date":107,"type":47},"2026-03-04",{"date":109,"type":47},"2024-12-27",{"date":111,"type":22},"2027-06-30",{"name":53,"class":54},18,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":4},"100625169","calibration-study-predict---prehospital-triage-for-suspected-acute-coronary-syndrome-without-st-segment-elevation-100625169","NCT07419139","Calibration Study PREDICT - Prehospital Triage for Suspected Acute Coronary Syndrome Without ST-segment Elevation","PREDICT","Inclusion Criteria:\n\n* Suspected myocardial infarction\n* Symptom onset \\>30 minutes before arrival of emergency medical services\n* Written informed consent\n\nExclusion Criteria:\n\n* STEMI on initial ECG\n* Unstable angina, hemodynamic instability, life-threatening arrhythmias, cardiac arrest\n* Non-ischemic causes requiring hospitalization\n* Emergency physician dispatch at the request of a primary care physician\n* Age \\\u003C18 years",true,{"count":123,"type":22},304,"OBSERVATIONAL","The PREDICT calibration study is a prospective, non-interventional trial aiming to adapt and calibrate the ACS-Pathfinder algorithm for prehospital triage of patients with suspected non-ST-elevation acute coronary syndrome (NSTE-ACS) in Germany. Approximately 304 patients will be enrolled by six emergency medical service (EMS) stations. All patients will receive standard care and an additional point-of-care troponin test (POCT) performed in the ambulance. Clinical and biomarker data will be collected using a study app, without influencing patient management. Follow-up will be conducted up to 90 days through telephone interviews and hospital record review.\n\nThe primary objective is to determine the true prevalence of myocardial infarction and calibrate the ACS-Pathfinder algorithm accordingly. Secondary objectives include assessing feasibility, workflow, acceptance, and data processes within the EMS as preparation for a subsequent cluster-randomized main study.\n\nThe study is coordinated by Prof. Holger Thiele (Heart Center Leipzig) with co-investigators from Leipzig and Hamburg. The sponsor is Leipzig Heart Science gGmbH. Study duration is planned from January to November 2026.",[127],"Acute Coronary Syndrome Without ST Elevation on Electrocardiogram",[129,130,131,132,133,134,135],"chest pain","shortness of breath","high-sensitivity troponin","ECG changes","Myocardial infarction (MI)","Pre-hospital care","Acute coronary syndrome without ST-segment elevation","2026-02-10",{"date":138,"type":47},"2026-02-18",{"date":140,"type":22},"2026-04",{"date":142,"type":22},"2026-11",{"name":53,"class":54},{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":151,"targetDuration":153,"studyType":124,"phases":4,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":169,"locationsCount":170},"100450179","german-cardiac-arrest-registry-100450179","NCT05142124","German Cardiac Arrest Registry","G-CAR","Inclusion Criteria:\n\n* patients with out-of-hospital cardiac arrest with assumed cardiovascular cause\n\nExclusion Criteria:\n\n* rejection of register participation by patient or legal representative",{"count":152,"type":22},400,"12 Months","In Germany, 70.000 to 100.000 patients suffer from out-of-hospital cardiac arrest (OHCA) every year. More than half of these are due to cardiac causes. Despite the medical progress over the last decades, rates of survival with good neurological outcome remain low. For many below-mentioned issues, no adequate evidence from randomized trials is available. Therefore, a systematic and standardized recording of the pre-clinical, clinical and post-clinical treatment course and of the clinical outcomes of OHCA patients is essential to improve patient care. Aim of the German Cardiac Arrest Registry (G-CAR) is to achieve a better understanding of the disease entity, leading to an optimized treatment of OHCA patients. The recorded data include information on demographic and psychosocial aspects, course of the disease, clinical, laboratory and other examinations as well as treatment modalities in patients with OHCA due to a cardiac cause.",[156],"Out-of-hospital Cardiac Arrest",[156,158,159,160,161,162,163],"OHCA","resuscitation","cardiac arrest center","acute care medicine","intensive care","post-resuscitation care",{"date":165,"type":47},"2026-02-12",{"date":167,"type":47},"2021-07-21",{"date":111,"type":22},{"name":53,"class":54},25,{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":182,"conditions":183,"keywords":186,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},"100499659","complete-revascularization-versus-culprit-lesion-only-pci-in-nstemi-100499659","NCT05786131","Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI","Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI (-COMPLETE-NSTEMI-)","CompleteNSTEMI","Inclusion Criteria:\n\n* NSTEMI as suggested by high-sensitivity troponin algorithms\n* Multivessel coronary artery disease\n* Identifiable culprit lesion\n* Informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Cardiogenic shock\n* Sustained ventricular tachycardia (VT) or ventricular fibrillation (VF)\n* Contraindication for coronary revascularization\n* Prior coronary artery bypass graft\n* Indication for coronary artery bypass graft surgery\n* Non-culprit lesion located in the left main coronary artery\n* Co-morbidity with life expectancy less than 6 months\n* Type 2 myocardial infarction\n* Pregnancy and breast feeding period",{"count":180,"type":22},3390,[25],"Prospective, randomized, controlled, multicenter, open-label trial to study whether multivessel percutaneous coronary intervention (PCI) is superior over culprit-lesion only PCI in patients with non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease.",[184,185],"Non-ST-elevation Myocardial Infarction","Multivessel Coronary Artery Disease",[187,188,189,190],"NSTEMI","Multivessel coronary artery disease","culprit-lesion only PCI","multivessel percutaneous coronary intervention","2025-01-15",{"date":193,"type":47},"2025-01-16",{"date":195,"type":47},"2023-10-27",{"date":197,"type":22},"2027-07-31",{"name":53,"class":54},58,{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":208,"targetDuration":209,"studyType":124,"phases":4,"briefSummary":210,"conditions":211,"keywords":214,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":224},"100467955","resuscitation-registry-in-chd-100467955","NCT05373498","Resuscitation Registry in CHD","Pediatric Resuscitation Outcome in Children With Heart Disease","PRO-CHD","Inclusion Criteria:\n\n* congenital heart defects, congenital heart arrhythmia, familial cardiomyopathies, inflammatory heart diseases\n* pediatric resuscitation (chest compressions ≥2min) in hospital or on arrival in hospital\n* age \\\u003C18 years\n* informed consent of the parents or legal representative\n\nExclusion Criteria:\n\n* absence or withdrawal of informed consent of the parents or legal representative\n* do-not-resuscitate-order (DNR)",{"count":152,"type":22},"24 Months","Children with congenital heart defects are far more likely to suffer a cardiovascular arrest and be in the need of cardiopulmonary resuscitation than healthy children or those with diseases of other organ systems, especially after cardiothoracic surgery. Due to a lack of data, the exact number of resuscitations in this patient cohort, as well as the morbidity and mortality, is unknown. This study aims to register all cardiovascular arrests in pediatric patients with congenital heart disease and study the mortality and morbidity with a special focus on the neurodevelopmental outcome.",[212,213],"Cardiac Arrest","Congenital Heart Disease",[215,216,217],"pediatric resuscitation outcome","congenital heart disease","neurodevelopmental outcome",{"date":193,"type":47},{"date":220,"type":47},"2022-08-18",{"date":222,"type":22},"2032-12-31",{"name":53,"class":54},3,""]