[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"IRCCS Policlinico S. Donato\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":678},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,46,74,100,125,148,173,198,221,250,270,295,328,363,384,423,443,470,495,528,556,577,600,628,652],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100620613","international-multicenter-study-of-the-navitornavitor-vision-transcatheter-aortic-valve-platform-100620613",false,"NCT07359898","International Multicenter Study of the Navitor\u002FNavitor Vision Transcatheter Aortic Valve Platform","International Multicenter Study of the Navitor\u002FNavitor Vision Transcatheter Aortic Valve Platform (The Intensive Study)","Intensive","Inclusion Criteria:\n\n1. Subject is referred to undergo TAVI with a Navitor\u002FNavitor Vision valve according to the local Heart Team. The Heart Team determines the indication for TAVI with Navitor\u002FNavitor Vision before possible enrolment and independently of the study.\n2. Subject is of legal age for consent in the host country.\n3. Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical site.\n\nExclusion Criteria:\n\n1. Pregnant or nursing subjects\n2. Need for emergency surgery for any reason\n3. Contraindications to Navitor\u002FNavitor Vision TAVI according to the IFU:\n\n   1. Any sepsis, including active endocarditis\n   2. Any evidence of left ventricular or atrial thrombus\n   3. Vascular conditions (i.e., stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve impossible\n   4. Non-calcified aortic annulus\n   5. Any leaflet configuration other than tricuspid\n   6. Inability to tolerate antiplatelet\u002Fanticoagulant therapy\n4. Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, individuals with severe dementia or individuals without legal authority\n5. Individuals who are unable to read or write","ALL","18 Years",{"count":21,"type":22},1000,"ESTIMATED","5 Years","OBSERVATIONAL","INTENSIVE is a prospective, single-arm, multi-center, international, investigator-initiated study of the Navitor\u002FNavitor Vision Transcatheter Aortic Valve (Navitor\u002FNavitor Vision Valve) in patients with symptomatic, severe native aortic stenosis to monitor the outcomes of this valve in a real-world clinical setting.",[27],"Severe Native Aortic Stenosis",[29,30,31,32],"Aortic Stenosis","TAVI","Navitor","Portico","RECRUITING","2026-07-23",{"date":36,"type":37},"2026-07-24","ACTUAL",{"date":39,"type":37},"2025-10-11",{"date":41,"type":22},"2031-10",{"name":43,"class":44},"IRCCS Policlinico S. Donato","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":45},"100647640","evaluation-of-the-accuracy-of-immunostaining-of-claudin-2-to-detect-active-or-inactive-inflammation-in-endoscopic-biopsies-of-ibd-100647640","NCT07710287","Evaluation of the Accuracy of Immunostaining of Claudin 2 to Detect Active or Inactive Inflammation in Endoscopic Biopsies of IBD","Histologic Healing in IBD: Comparison of \"Standard\" Scores With Expression of Claudin 2 and Impact on Outcomes","LOGIC-2","Inclusion Criteria:\n\nConfirmed diagnosis of IBD\n\nExclusion Criteria:\n\nUnconfirmed diagnosis of IBD",{"count":55,"type":22},100,"In view of the increasing evidence of the importance of mucosal healing as a combination of endoscopic and histologic healing, and the complexity and lack of complete agreement of the evaluation of histologic healing in IBD, the aim of this study will be to evaluate the accuracy of a new methodology, the immunostaining for Claudine 2 as compared to others standard well-accepted scoring for histologic activity in IBD. The aim is compare the accuracy of this methodology and in addition the correlation with outcomes (i.e. relapse, hospitalization, surgery).",[58,59],"Ulcerative Colitis (UC)","Crohn Disease",[61,62,63,64,65],"Ulcerative colitis","Crohn's disease","Histology","Mucosa healing","Claudin","2026-07-13",{"date":68,"type":37},"2026-07-17",{"date":70,"type":37},"2025-02-14",{"date":72,"type":22},"2027-09",{"name":43,"class":44},{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":45},"100614108","impact-of-prontosan-wound-gel-x-on-surgical-site-infections-in-cardiac-surgery-100614108","NCT07275307","Impact of Prontosan Wound Gel X on Surgical Site Infections in Cardiac Surgery","Evaluating the Effects of Prontosan Wound Gel X on the Occurrence of Superficial Surgical Site Infections in Adult Cardiac Surgery Patients: A Single-Arm, Phase IV, Adaptive Feasibility Study","PRONTOSAN","Inclusion Criteria:\n\n* Scheduled for elective cardiac surgery requiring median sternotomy (e.g., CABG, valve surgery, aortic surgery)\n* Ability to provide informed consent\n* Independent clinical decision by the treating surgeon to apply Prontosan Wound Gel X during surgery, irrespective of study enrollment\n\nExclusion Criteria:\n\n* Urgent or emergency surgery\n* Concurrent enrollment in interventional clinical trials\n* Known hypersensitivity to components of Prontosan Wound Gel X\n* Local skin conditions or infections at the planned incision site that preclude safe use of topical antiseptic products",{"count":83,"type":22},456,"This study aims to evaluate the effects of Prontosan® Wound Gel X on the incidence of superficial surgical site infections (SSI) in adult patients undergoing elective cardiac surgery with median sternotomy. The primary objective is to assess how the intraoperative application of the gel impacts the occurrence of SSIs, defined according to CDC\u002FNHSN criteria. Secondary objectives include evaluating the length of hospital stay, the incidence of unplanned re-operations, and identifying any latent clinical subgroups through clustering analysis.\n\nThe study will be conducted as a prospective, single-center, observational, post-market trial. The primary endpoint will be the incidence of SSIs during the post-operative hospitalization period, while secondary endpoints will focus on hospital stay duration, re-operation rates, and feasibility indicators such as adherence to the protocol and completeness of data collection. The study also includes an exploratory endpoint where hierarchical clustering will be used to identify clinical subgroups based on demographic, clinical, and procedural variables.\n\nUp to 456 adult patients will be enrolled, all of whom are undergoing elective cardiac surgery via median sternotomy at IRCCS Policlinico San Donato. The inclusion criteria include patients aged 18 or older, scheduled for surgery, and able to provide informed consent, with the clinical decision to use Prontosan® Wound Gel X during the surgery. Exclusion criteria involve urgent surgeries, participation in other interventional studies, known hypersensitivity to the gel components, or existing skin conditions incompatible with its use.\n\nThe study duration is estimated to be approximately 18 months, depending on patient enrollment and discharge rates. The follow-up will align with the hospital stay, from the surgery date to discharge, with no post-discharge follow-up planned. Statistical analysis will include a binomial test to compare observed SSI rates with those reported in literature, while secondary data will be analyzed descriptively. An exploratory analysis will use clustering to explore latent clinical subgroups.",[86],"Surgical Site Infection After Major Surgery",[88,89,90,91],"Surgical site infection","SSI","Prontosan","Surgery","2026-07-03",{"date":94,"type":37},"2026-07-07",{"date":96,"type":37},"2026-02-02",{"date":98,"type":22},"2027-12",{"name":43,"class":44},{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":45},"100576429","dynamic-cardio-vascular-cerebro-vascular-and-cortical-interaction-in-healthy-adult-subjects-100576429","NCT06785181","Dynamic Cardio-vascular, Cerebro-vascular and Cortical Interaction in Healthy Adult Subjects","Dynamic Cardio-, Cerebro-vascular and Cortical Interaction in Healthy Adult Subjects","IDEALE","Inclusion Criteria:\n\n* age older than 18 years\n* spontaneous sinus rhythm\n* signed informed consent\n\nExclusion Criteria:\n\n* Definite diseases of the Autonomic Nervous System (SNA) or the cardiovascular system\n* Central nervous system disorders\n* subjects under drug therapy that may affect the cardiovascular system\n* pregnancy\n* previous diagnosis of depression",true,{"count":110,"type":22},50,"INTERVENTIONAL",[113],"NA","IDEALE aims to assess the status of autonomic function, cerebral autoregulation (CA) and cortical activity in healthy subjects and correlate these functions with the psychological dimension of the subjects.\n\nTo this end, parameters of cardiac, cortical, vascular and cerebrovascular variability derived from electrocardiographic, electroencephalographic, respiratory movement, blood pressure, transcranial Doppler signals will be acquired and analysed for each healthy volunteer (TCD) and Laser-Doppler transcutaneous, during a phase of clinostatism (REST) and one of active orthostatism (STAND). In addition, volunteers will be submitted to psychometric tests (Chieti Affective Action Videos, CAAV) to assess the presence of depressive symptoms.",[116],"Cardiac Disease","2026-07-02",{"date":119,"type":37},"2026-07-06",{"date":121,"type":37},"2024-10-03",{"date":123,"type":22},"2027-10-03",{"name":43,"class":44},{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":111,"phases":135,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":45},"100499670","predicting-cerebrovascular-adverse-events-post-cardiac-surgery-100499670","NCT05786274","Predicting Cerebrovascular Adverse Events Post Cardiac Surgery","Predicting Cerebrovascular Adverse Events Post Cardiac Surgery With Cardiopulmonary Bypass by Means of Cerebral AutoreguLation Indices","PASCAL","Inclusion Criteria:\n\n* age older than 18 years\n* spontaneous sinus rhythm\n* no pregnancy\n* signed informed consent\n\nExclusion Criteria:\n\n* age lower than 18 years\n* absence of sinus rhythm\n* autonomic disorders\n* concomitant carotid intervention\n* reintervention\n* contraindication to MRI\n* pregnancy\n* impossibility of informed consent",{"count":134,"type":22},104,[113],"The aims of this study are: i) to assess cerebral autoregulation and autonomic control within the different phases of cardiac surgery with cardiopulmonary bypass; ii) to compare cerebral autoregulation measures derived via cerebral blood flow velocity estimated by transcranial Doppler device with simpler measurements derived from near infrared spectroscopy; iii) to develop a predictive model of postoperative cerebrovascular outcome (overt or silent stroke) based on the extracted indices.",[116],[139,140,141],"cerebral autoregulation","cardiopulmonary bypass","stroke",{"date":119,"type":37},{"date":144,"type":37},"2023-04-01",{"date":146,"type":22},"2026-12-31",{"name":43,"class":44},{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":108,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":158,"conditions":159,"keywords":163,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":45},"100493544","cardiovascular-and-cerebrovascular-control-in-healthy-subjects-100493544","NCT05706532","Cardiovascular and Cerebrovascular Control in Healthy Subjects","Cardiovascular and Cerebrovascular Control in Healthy Adult Subjects","CardioSan","Inclusion Criteria:\n\n* age \\>18\n* sinus rhythm\n* informed consent signed\n\nExclusion Criteria:\n\n* age \\\u003C18\n* presence of autonomic nervous system diseases or dysfunctions",{"count":157,"type":22},60,"The aim of the study is to evaluate autonomic function and cerebrovascular control in 60 healthy subjects by means of noninvasive analysis of time series variability.\n\nTo this extent, heart period, systolic and mean arterial blood pressure, cerebral blood velocity, peripheral resistances, respiration will be recorded from subjects during an orthostatic challenge.\n\nThe interactions between autonomic cardiovascular function, cerebrovascular and peripheral control will be evaluated exploiting the most advanced signal processing techniques.",[160,161,162],"Healthy","Autonomic Nervous System","Cerebral Autoregulation",[164,165,139,166],"autonomic nervous system","heart rate variability","peripheral resistances",{"date":119,"type":37},{"date":169,"type":37},"2023-05-29",{"date":171,"type":22},"2027-10",{"name":43,"class":44},{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":182,"conditions":183,"keywords":186,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":45},"100614678","fibroblast-line-evaluation-for-col5a-expression-and-thoracic-aortic-aneurysms-in-vitro-characterization-of-cutaneous-fibroblasts-in-adult-patients-100614678","NCT07282717","Fibroblast Line Evaluation for COL5A eXpression and Thoracic Aortic Aneurysms: in Vitro Characterization of Cutaneous Fibroblasts in Adult Patients","FLEX5 project","Inclusion Criteria:\n\n* Subjects aged 18 and above\n* Mutation in COL5A\n* Signed informed consent\n\nExclusion Criteria:\n\n* Corticosteroid or Steroids or Fluorochinolones treatment within six months before enrollment\n* Subjects on chronic immunosuppressive therapies such as oral steroids, but also on chronic topical steroids in the area of investigation\n* Subject on anticoagulant therapy\n* History of coagulation factor defects\u002Falterations (data found in anamnesis and medical records)\n* A history of keloid formation (data found in anamnesis and medical records)\n* Anesthetic drug allergy (data found in anamnesis and medical records)",{"count":181,"type":22},20,"This study examines adults with COL5A gene mutations to understand why some develop aortic aneurysms while others do not. Participants provide a small skin biopsy, and researchers analyze fibroblasts to evaluate collagen production, extracellular matrix organization, and connective-tissue signaling pathways. The goal is to identify biological differences that may explain variable vascular risk and support future personalized monitoring and treatment strategies.",[184,185],"Mutations Affecting the COL5A Gene","Aneurysm Aortic",[187,188,189,190],"COL5A","FIBROBLASTS","ascending and descending aortic aneurysms","thoracic aortic aneurysms","2026-07-01",{"date":117,"type":37},{"date":194,"type":37},"2026-06-24",{"date":196,"type":22},"2028-12",{"name":43,"class":44},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},"100584055","functional-capacity-in-anderson-fabry-disease-patients-100584055","NCT06884358","Functional Capacity in Anderson-Fabry Disease Patients","FunctiOnal caPaciTy Evaluation Using cardIopulMonary Testing and Stress echocArdiography in Anderson-Fabry Disease Patients: OPTIMA-FD Study","OPTIMA-FD","Inclusion Criteria:\n\n* Patients with a genetic diagnosis of AFD, according to current guidelines;\n* Informed written consent with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care (for patients age \\\u003C18 years old, written consent from a caregiver is mandatory).\n\nExclusion Criteria:\n\n* eGFR \\\u003C30 ml\u002Fmin and other contraindications for CMR (relative controindication: patients with implantable device);\n* Musculoskeletal limitation for exercise test on the cyclo ergometer;\n* Pregnant or breastfeeding women;\n* Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with a full comprehension of the written consent form.",{"count":55,"type":22},"The goal of this observational study is to observe the relation between excercise parameters - assessed by CPET - and rest\u002Fstress hemodynamic parameters - assessed by echocardiogram and CMR - in patients with a genetic diagnosis of Anderson-Fabry Disease.\n\nParticipants will undergo:\n\n* baseline evaluation: clinical evaluation, disease staging with FASTEX and MSSI, KCCQ for quality of life assessment, resting 12-leads ECG, 6MWT, CPET-ESE and contrast-enhanced CMR;\n* before 36 months from baseline: resting 12-leads ECG, 2D rest and stress echocardiogram, CPET-ESE, contrast-enhanced CMR, disease staging with FASTEX and MSSI and KCCQ for quality of life assessment;\n* up to 7 years from baseline: clinical follow-up.",[209],"Anderson-Fabry Disease",[209,211,212,213],"Cardiac Involvement","CMR","CPET",{"date":117,"type":37},{"date":216,"type":37},"2024-11-13",{"date":218,"type":22},"2032-01",{"name":43,"class":44},5,{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":111,"phases":230,"briefSummary":231,"conditions":232,"keywords":234,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},"100582126","in-vitro-benchmarking-of-currently-available-heart-valve-prostheses-for-surgical-and-percutaneous-treatment-of-aortic-stenosis-with-small-annulus-followed-by-in-vivo-validation-100582126","NCT06859255","In-vitro Benchmarking of Currently Available Heart Valve Prostheses for Surgical and Percutaneous Treatment of Aortic Stenosis With Small Annulus, Followed by In-vivo Validation","SurPASS","Inclusion Criteria:\n\n* patients who underwent SAVR or TAVI for severe aortic stenosis\n* implanted with valve models and sizes among those which we evaluated in vitro\n\nExclusion Criteria:\n\n* treated or untreated aortic root\u002Fascending aorta aneurysm\n* preoperative aortic regurgitation more than moderate\n* recent (\\\u003C12 weeks)\u002F concomitant revascularization\n* recent (\\\u003C12 weeks) ACS\n* PPI (permanent pacemaker implantation)\n* other than sinus rythm\n* Paravalvular leak (PVL) \\> moderate.",{"count":229,"type":22},200,[113],"The general objective of this study is to compare in vitro and in vivo the hemodynamic performance of different types of aortic valve prostheses and possible surgical implantation techniques.\n\nThe study involves the collection of data deriving from tests and procedures foreseen by normal clinical practice, including a transthoracic color Doppler echocardiogram, to which is added a 4DFlow cardiac MRI (magnetic resonance imaging) without contrast medium, to be performed between 1 and 3 months after the operation.\n\nThe study will last 24 months and the patients involvement will end approximately 1-3 months after the intervention.\n\nThere are no direct benefits expected from participation in the study. However, the instrumental data obtained by echocardiogram and Magnetic Resonance Imaging will be useful for monitoring the medium-term surgical outcome of patients after surgery.",[233],"Severe Aortic Valve Stenosis",[235,236,30,237,238,239,240,241,242],"aortic valve stenosis","valve replacement","hemodynamic","4d flow","cardiac echo","cardiac RMN","aortic valve","TAVR",{"date":117,"type":37},{"date":245,"type":37},"2025-02-07",{"date":247,"type":22},"2027-02-07",{"name":43,"class":44},2,{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":111,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":264,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":45},"100534892","pain-control-after-aortic-endoaneurysmectomy-popeye-100534892","NCT06244732","Pain Control After Aortic EndoaneurYsmEctomy (POPEYE)","Post-Operative Pain Control After Aortic EndoaneurYsmEctomy","POPEYE","Inclusion Criteria:\n\n* adult patients (age \\> 18 years)\n* patients who have given their consent to participate in the study\n* patients undergoing elective \"open\" surgical treatment of an abdominal aortic aneurysm with a midline xipho-pubic incision.\n\nExclusion Criteria:\n\n* Pregnant women\n* Patients being treated for chronic pain\n* Known allergy to drugs included in analgesia protocols\n* Contraindications to the use of one of the two methods provided:\n\n  * refusal by the patient\n  * infection at the puncture site\n  * coagulopathy:\n\n    1. PTT \\> 40 s and\u002For INR \\> 1.4\n    2. platelet count \\\u003C 50,000\u002FµL\n    3. taking antiplatelet or anticoagulant drugs that have not been discontinued in good time, according to international guidelines\n* Emergent intervention\n* Lack of consent to participate in the study",{"count":157,"type":22},[113],"Open abdominal aortic aneurysm repair (OR-AAA) is an operation associated with high morbidity, and has 30-day mortality rates of between 4 and 14%. Post-operative pain management represents a primary anesthetic focus.\n\nA better analgesia, in addition to being desirable for the patient, can potentially reduce complications associated with postoperative pain and ensure faster functional recovery.\n\nThe modern concept of multimodal analgesia involves the association of multiple drugs and\u002For analgesic techniques to maximize the quality of analgesia and reduce the side effects of the individual methods. In this context, the addition of epidural analgesia (EA) to the intravenous administration of \"traditional\" analgesic drugs has assumed the role of gold standard in many surgeries, including OR-AAA.\n\nOver time, EA has proven to be a better analgesic technique than the use of intravenous opioids alone, however there is much uncertainty regarding its ability to reduce complications, morbidity and mortality of patients.\n\nFor some time, efforts to research effective, less invasive and safe anesthetic alternatives, have been directed towards the development of multimodal analgesia protocols with the aim of reducing complications and ensuring faster recovery. New approaches to post-operative pain management are emerging, including rectus sheat block (RSB).\n\nCurrently there is no evidence regarding the effectiveness of RSB in pain control after OR-AAA.\n\nIn this context, the study aims to compare two different post-operative pain management protocols, with the aim of verifying whether the use of RSB can guarantee a non-inferior level of analgesia with reduction of complications compared to AE.",[262,263],"Postoperative Pain","Abdominal Aortic Aneurysm",{"date":117,"type":37},{"date":266,"type":37},"2024-02-19",{"date":268,"type":22},"2027-03",{"name":43,"class":44},{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":279,"conditions":280,"keywords":283,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":45},"100482766","multicentric-study-on-clopidogrel-resistance-in-dapt-for-cas-multi-resclosa-100482766","NCT05566301","Multicentric Study on Clopidogrel Resistance in DAPT for CAS (MULTI-RESCLOSA)","MULTIcentric Study About RESistance to CLOpidogrel in Dual Antiplatelet Therapy for Carotid Stenting","Inclusion Criteria:\n\n* adult patients (age\\> 18 years)\n* patients who have given their consent to participate in the study, belonging to the U.O. of Vascular Surgery of the IRCCS Policlinico San Donato and the U.O. of Vascular Surgery of the participating centers and subjected to the treatment of carotid stenosis by stenting technique.\n\nExclusion Criteria:\n\n* underage patients\n* patients who have not given their consent to participate in the study,\n* patients who have carotid stenosis not susceptible to intervention by stenting\n* pregnant or lactating women (such as situations in which carotid stenting is contraindicated regardless of the execution of the study).",{"count":278,"type":22},1140,"Spontaneous prospective observational multicentre pharmacological study that aims to evaluate whether, from a statistical point of view, there is a significant difference between the use of Ticagrelor in \"non-responders\" patients to Clopidogrel undergoing carotid stenting and Clopidogrel in \"responders\" undergoing carotid stenting, in the onset of death and major adverse cardiovascular events (MACE) and bleeding events, 1 and 3 months after the procedure. Furthermore, the study aims to evaluate the possible preoperative clinical and pharmacological factors most associated with the phenomenon of resistance to Clopidogrel.\n\nInclusion criteria:\n\nThe data will be collected on adult patients (age\\> 18 years) who have given their consent to participate in the study, belonging to the U.O. of Vascular Surgery of the IRCCS Policlinico San Donato and the U.O. of Vascular Surgery of the participating centers and there subjected to the treatment of carotid stenosis by stenting technique.\n\nExclusion criteria:\n\nThose patients who are minors, who have not given their consent to participate in the study, or who have carotid stenosis not susceptible to intervention by stenting will be excluded from the study. Pregnant or lactating women will also be excluded from the study (such as situations in which carotid stenting is contraindicated regardless of the execution of the study).",[281,282],"Clopidogrel, Poor Metabolism of","Carotid Stenosis",[284,285,286,287,288],"clopidogrel resistance","carotid artery stenting","carotid stenosis","dual antiplatelet therapy","ticagrelor",{"date":117,"type":37},{"date":291,"type":37},"2021-09-02",{"date":293,"type":22},"2030-12-31",{"name":43,"class":44},{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":108,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":305,"conditions":306,"keywords":309,"overallStatus":319,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":4},"100644418","cardiovascular-risk-in-patients-with-ibd-100644418","NCT07663201","Cardiovascular Risk in Patients With IBD","Dissecting the Complexity of Inflammatory Bowel Disease (IBD) A Prospective Study With Focus on Cardiovascular Risk","DICOM-IBD","Inclusion Criteria:\n\nEstablished diagnosis of ulcerative colitis and Crohn's disease\n\nExclusion Criteria:\n\nAge \\> 18 years Not compliant with study protocol",{"count":304,"type":22},300,"In this study our Research Hospital San Donato Policlinic ask your partipation with the aim to evaluate the risk of cardiovascular complication (i.e. stroke, myocardial infarction) in patients with inflammatory bowel disease. Multiple parameters (therapy, disease activity, life style) and investigations (DNA, stool, lab tests) will be evaluate with the support of artificial intelligence methodologies to better define the cardiovascular risk.",[58,307,308],"Crohn's Diseases","Cardiovascular Risk",[61,62,310,311,312,313,314,315,316,317,318],"Inflammatory bowel disease","Cardiovascular risk","Stroke","Cardiovascular death","Myocardial infarction","Atrial fibrillation","Ischemic heart disease","Major cardiovascular events","Acute Arterial events (i.e. pulmonary embolism)","NOT_YET_RECRUITING","2026-06-17",{"date":322,"type":37},"2026-06-23",{"date":324,"type":22},"2026-09",{"date":326,"type":22},"2029-12",{"name":43,"class":44},{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":18,"minAge":336,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":111,"phases":339,"briefSummary":340,"conditions":341,"keywords":352,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":45},"100570323","speed-up-the-diagnosis-and-evaluation-of-anomalous-coronary-artery-from-the-aorta-100570323","NCT06705751","Speed-up the Diagnosis and Evaluation of anoMalous Coronary ARTery From the Aorta","SMART: Speed-up the Diagnosis and Evaluation of anoMalous Coronary ARTery From the Aorta.","SMART","Inclusion Criteria:\n\n* Adult and pediatric patients (age \\> 6 years) with anomalous coronary origin from the aorta (AAOCA).\n* Patients in spontaneous sinus rhythm.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients with acute and chronic inflammatory conditions such as chronic liver disease, chronic kidney failure (creatinine \\> 1.5 mg\u002Fdl), and thyroid disorders.\n* Patients with arrhythmias, absence of sinus rhythm.\n* Contraindications to autonomic testing.\n* Patients with a known allergy to materials in recording devices.\n* Female patients who are pregnant.","6 Years",{"count":338,"type":22},38,[113],"Anomalous aortic origin of the coronary arteries (AAOCA) is a rare congenital disease and one of the leading causes of sudden cardiac deaths (SCD) in young athletes but also has a lethal presentation in adult age with myocardial infarction, even if not related to obstructive coronary arteries. Unfortunately, diagnostic imaging techniques, invasive assessment, and provocative stress tests have shown low sensitivity and specificity in detecting inducible ischemia, and a multimodality assessment is then necessary.\n\nInnovative tools have been developed in the medical field using computer-based simulation, 3-dimensional reconstruction, machine learning, and artificial intelligence (AI). With the application of such new technologies, we aim to fill the gap of knowledge and the diagnostic limitation regarding risk stratification for most subjects with AAOCA.\n\nThis work seeks to enhance, fasten, and personalize the clinical diagnosis of AAOCA by integrating anatomical measurements, clinical data, and biomechanical patient-specific features. The SMART study will set a system to automatically segment and classify coronary arteries with AAOCA from computerized tomography angiography (CTA) by artificial intelligence (AI). Segmentation will feed a 3D model of the aortic root and coronary artery for biomechanical assessment through finite element analysis (FEA). This will allow us to assess the location of possible coronary artery compression under an effort condition. These in-silico results, the anatomical features measured by AI, and the clinical data will be integrated into a risk model to estimate the hazard risk of adverse events such as SCD or myocardial infarction. This workflow will be framed in an IT system to allow a web-based remote diagnostic service.\n\nThanks to the proposed multidisciplinary approach, SMART aims to overcome the current diagnostic limitations related to the reduced ability of functional stress tests to detect ischemia. Potentially helping in patient-specific risk stratification, SMART is also thought to provide a way to get a first diagnostic indication about AAOCA being accessible from any hospital, fostering the diffusion of peripheral territorial support to the diagnosis and treatment of such rare disease.",[342,343,344,345,346,347,348,349,350,351],"AAOCA","ACAOS","Anomalous Aortic Origin of the Coronary Artery (AAOCA)","Anomalous Coronary Artery Arising From the Opposite Sinus","Anomalous Coronary Artery Origin","Anomalous Coronary Artery With Aortic Origin and Course Between the Great Arteries","Coronary Anomaly","Sudden Cardiac Death","Myocardial Ischemia","Myocardial Ischemia, Angina Pectoris",[342,353,354,343],"CT","IMAGE SEGMENTATION","2026-04-10",{"date":357,"type":37},"2026-04-15",{"date":359,"type":37},"2024-09-12",{"date":361,"type":22},"2027-02",{"name":43,"class":44},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":45},"100533791","t-mem-gene-in-atherosclerosis-100533791","NCT06230406","T-Mem GEne in Atherosclerosis","Role of T-Mem GEne in the Molecular Pathogenesis of Atherosclerosis","GEMMA","Inclusion Criteria:\n\n* adult patients (age \\> 18 years)\n* consent to participate in the study,\n* patients coming to the Vascular Surgery Unit I of the IRCCS Policlinico San Donato for a vascular pathology of the arterial or venous district worthy of surgical treatment.\n\nExclusion Criteria:\n\n* minor patients,\n* patients who have not given their consent to participate in the study,\n* patients who have vascular pathologies of the arterial or venous district not susceptible to surgical intervention.",{"count":372,"type":22},12,"Atherosclerosis is the main cause of cardiovascular diseases and is characterized by the progressive accumulation of lipids and inflammatory cells such as macrophages and lymphocytes within the vessel wall of large and medium-sized arteries, forming the so-called \"atherosclerotic plaques\". The formation process of these lesions is different depending on the age, genetics and physiological state of the individual affected. Furthermore, behavioral factors and the lifestyle of each individual play a key role, which can lead to the presence of a series of pro-atherosclerotic pathologies and risk factors, such as in particular systemic arterial hypertension, dyslipidemia, hyperglycemia and cigarette smoking. However, the precise molecular mechanisms underlying this pathogenetic process are still under investigation.\n\nThe results of a study conducted in the past in collaboration between the U.O. have recently been published. of Vascular Surgery and the laboratory of Dr. I. Zucchi of the Institute of Biomedical Technologies of the CNR of Milan Segrate (Protocol GEMMA NUOVA, 16\u002Fint\u002F2016), which describes that the overexpression of a newly identified gene (TMEM230) it may have a role in the formation of atherosclerotic vascular disorders, but it is still unclear how the expression of this gene is modulated in vivo.\n\nKnowledge of these factors would increase the knowledge of the molecular mechanisms underlying atherosclerosis and could represent a possible target for prevention and targeted pharmacological treatment, with consequent potential reduction in disability or mortality from cardiovascular diseases.",[375],"Atherosclerosis","2026-04-01",{"date":378,"type":37},"2026-04-07",{"date":380,"type":37},"2023-09-28",{"date":382,"type":22},"2026-12",{"name":43,"class":44},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":391,"minAge":19,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":111,"phases":395,"briefSummary":397,"conditions":398,"keywords":404,"overallStatus":319,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":422},"100615662","phase-4-pharmacological-optimization-in-prevention-in-heart-failure-a-sex-gap-100615662","NCT07295522","Pharmacological Optimization in Prevention in Heart Failure: A Sex-gap?","PopS-HF","Inclusion Criteria:\n\n1. Female patients \\>18 \\\u003C85 years.\n2. Hospital admission within the 72 hours prior to Screening for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and\u002For symptoms of heart failure such as edema and\u002For positive rales on auscultation.\n3. All measures within 24 hours prior to Randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.\n4. All measures within 24 hours prior to Randomization of serum potassium ≤ 5.0 mEq\u002FL (mmol\u002FL).\n5. Biomarker criteria for persistent congestion:\n\n   5.1. At Screening, NT-proBNP \\>1,800 pg\u002FmL (2,350 pg\u002FmL in case of atrial fibrillation) 5.2. At the time of Randomization (1-2 days prior to discharge), NT-proBNP \\>1,000 pg\u002FmL (1,300 pg\u002FmL in case of Atrial Fibrillation) to ensure the persistence of congestion and the acuity of the index episode).\n6. At 1 week prior to admission, at Screening, and at Visit 2 6.1. If EF\\\u003C50% (ie HFrEF or HFmrEF) either \\\u003C½ the optimal dose of ACEi\u002FARB\u002FARNi and MRA and BB or no SGLT2i (see Table) must have been prescribed 6.2. If EF\\>50% (ie HFpEF): \\\u003C½ the optimal dose of MRA (see Table) or no SGLT2i.\n7. Written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Male patients\n2. Age \\\u003C 18 or \\> 85 years.\n3. Mechanical ventilation (not including CPAP\u002FBIPAP) in the 24 hours prior to Screening.\n4. Significant pulmonary disease contributing substantially to the patients' dyspnoea such as FEV1 \\\u003C1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as primary pulmonary hypertension or recurrent pulmonary embolism.\n5. Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy (CRT) device implantation within 3 months, or percutaneous transluminal coronary intervention (PTCI), within 1 month prior to Screening or during the index event.\n6. Index Event (admission for Acute Heart Failure) triggered primarily by a correctable aetiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation\u002Fflutter with sustained ventricular response \\>130 beats per minute, or bradycardia with sustained ventricular arrhythmia \\\u003C45 beats per minute), infection, severe anaemia, acute coronary syndrome, pulmonary embolism, exacerbation of Chronic Obstructive Pulmonary Disease (COPD), planned admission for device implantation or severe non-adherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not an exclusion.\n7. Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.\n8. History of heart transplant or on a transplant list or using or planned to be implanted with a ventricular assist device.\n9. Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated.\n10. Presence at Screening of any hemodynamically significant valvular stenosis or regurgitation, except mitral or tricuspid regurgitation secondary to left ventricular dilatation, or the presence of any hemodynamically significant obstructive lesion\n11. Active infection at any time during the AHF hospitalization prior to Randomization based on abnormal temperature and elevated WBC or need for intravenous antibiotics.\n12. Stroke or Transient Ischemic Attack (TIA) within the 3 months prior to Screening.\n13. Primary liver disease considered to be life threatening.\n14. Renal disease or eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2 (as estimated by the simplified MDRD formula) at Screening or history of dialysis.\n15. Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy \\\u003C 6 months.\n16. Prior (defined as less than 30 days from screening) or current enrollment in a CHF trial or participation in an investigational drug or device study within the 30 days prior to screening or 5 half-lives of the study drug, whichever is longer.\n17. Discharge for the AHF hospitalization anticipated to be \\>14 days from admission, or to a long-term care facility. Randomization must occur within 12 days following admission and at 1-2 days prior to anticipated discharge.\n18. Inability to comply with all study requirements, due to major co-morbidities, social or financial issues or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and\u002For comply with the protocol instructions or follow-up procedures.\n19. Pregnant or nursing (lactating) women.\n20. Hypersensitivity to the active substance or to any of the excipients as indicated in Summary of Product Characteristics of Investigational Medicinal Product (IMPs).\n21. Angioedema.\n22. Severe heart failure (NYHA class IV).","FEMALE","85 Years",{"count":394,"type":22},368,[396],"PHASE4","The goal of this clinical trial is to learn whether a rapid and intensive optimization of heart failure medications in women can improve outcomes after hospitalization for heart failure. It will also investigate the safety and the tolerance of these treatments when given at full guideline-recommended doses.\n\nThe main questions it aims to answer are:\n\n1. Does intensive medication optimization reduce death or hospital readmissions for heart failure within one year?\n2. Do women benefit as much as men from intensive and full-dose heart failure therapy?\n3. Is this treatment protocol safe and feasible also in women?\n\nResearchers will compare two groups of women hospitalized for heart failure:\n\n* High-intensity care: starting and increasing all recommended heart-failure medications as quickly as possible and monitoring patients closely during the first weeks after discharge.\n* Usual care: medications are started and adjusted gradually, according to the judgment of the treating cardiologist and the patient's usual care team.\n\nThe study will follow participants for 12 months to see whether the high-intensity strategy reduces death, hospital readmission for heart failure, or worsening symptoms. It will also evaluate side effects, medication tolerance, and quality of life.\n\nParticipants will be randomly assigned to one of the two groups, attend regular follow-up visits for one year, complete a short quality-of-life questionnaire (EQ-5D).\n\nThis study will include about 360 women from 13 hospitals in Italy. It is sponsored by IRCCS Policlinico San Donato and funded by the Italian Medicines Agency (AIFA).",[399,400,401,402,403],"Heart Failure","Acute Heart Failure","Heart Failure With Reduced Ejection Fraction (HFrEF)","Heart Failure With Preserved Ejection Fraction (HFPEF)","Heart Failure With Mildly Reduced Ejection Fraction",[405,406,407,408,409,410,411,412,413],"heart failure","women","GDMT","Pharmacological Optimization","phase IV","High intensity up-titration","Secondary prevention","Sex differences","Real world data","2026-03-25",{"date":416,"type":37},"2026-03-30",{"date":418,"type":22},"2026-04-08",{"date":420,"type":22},"2028-06-08",{"name":43,"class":44},13,{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":108,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":111,"phases":431,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":45},"100538690","multivariate-approach-to-the-numerical-assessment-of-cortical---autonomic---vascular-dynamic-interplay-100538690","NCT06294119","Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay","Inclusion Criteria:\n\n* age older than 18 years\n* spontaneous sinus rhythm\n* signed informed consent\n* indication to heart surgery\n\nExclusion Criteria:\n\n* age lower than 18 years\n* absence of sinus rhythm\n* pregnancy\n* impossibility of informed consent",{"count":430,"type":22},80,[113],"MANCAVA sets out fundamental methodologies for characterizing human fundamental physiological system interactions at a whole-body level, particularly focusing on the interplay among cortical brain activity, autonomic function, and cerebrovascular autoregulatory mechanisms. By investigating the complex, time-varying mechanisms underlying the multisystem dynamic interactions, novel methods linking various brain areas and reflex functions to target organs and districts such as heart and circulatory system are proposed with the clinical aim linked to the emerging topic of depression.\n\nIn this scenario, proper new mathematical tools will allow a significant leap from the current state of the art, paving the way towards a new understanding of leading comorbid contributors to global diseases such as cardiac and cerebrovascular morbidity in mood disorders. In turn, this will provide an integration among physiological and psychological dimensions for a more holistic view on depression.\n\nResearchers, professionals, and patients will all benefit from a comprehensive assessment of brain-mind-body interplay, leading to the new extended definition of default mode\u002Fmood network, neurovascular-evoked responses to autonomic stimuli, brain-autonomic consequences of emotional responses, and physiological substrates of depressive states.",[116,434],"Depression","2026-03-23",{"date":437,"type":37},"2026-03-27",{"date":439,"type":37},"2025-09-30",{"date":441,"type":22},"2029-02-28",{"name":43,"class":44},{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":453,"conditions":454,"keywords":456,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":469,"locationsCount":45},"100627793","strength-tracking-from-wall-tichness-over-aortic-biomechanics-storm-100627793","NCT07453251","Strength Tracking From Wall Tichness Over Aortic Biomechanics (STORM)","Strength Tracking From Wall Tichness Over Aortic Biomechanics","STORM","Inclusion Criteria:\n\n* Patients undergoing cardiac surgery for either aortic root and\u002For ascending aortic aneurysms; • Patients that have received, understood and signed the written informed consent for this study.\n\nExclusion Criteria:\n\n* Patients that have already undergone previous cardiac surgery; • Patients that present with acute aortic pathologies, such as acute aortic dissection or intramural hematoma.",{"count":452,"type":22},40,"The aim of the study is to analyse the resected portion of aneurysmatic ascending aorta in order to assess its strength to rupture, standardise the various measurements performed within the lab and try to correlate these qualitative results with quantitative results (regarding aortic diameter, valve morphology and aortic wall thickness).",[185,455],"Aneurysm Aortic Root",[457,458,459,460,461,462],"aortic aneurysm","bicuspid aortic valve","tricuspid aortic valve","tensile testing","aortic strength","aortic rupture","2026-03-09",{"date":465,"type":37},"2026-03-11",{"date":467,"type":37},"2025-10-25",{"date":382,"type":22},{"name":43,"class":44},{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":111,"phases":479,"briefSummary":480,"conditions":481,"keywords":485,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":249},"100627950","phenotyping-left-ventricle-failure-with-hemodynamic-biomarkers-from-4d-flow-magnetic-resonance-imaging-100627950","NCT07455292","Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging","TRANSLATE","Inclusion Criteria:\n\n* Adult patients (age \\> 18 years old);\n* Diagnosis of severe AS defined according to ESC guidelines with indication to TAVR;\n* Severe aortic stenosis both in normal\u002Fhigh flow status and in low flow status;\n* Signed informed written consent.\n\nExclusion Criteria:\n\n* Contraindication to cardiac MRI due to previous implant with ferromagnetic components;\n* Poor MRI quality impairing image post-processing;\n* Claustrophobia;\n* Unwilling to sign the informed consent.",{"count":478,"type":22},190,[113],"This study aims to enhance and streamline intracardiac 4D Flow magnetic resonance imaging (MRI) processing by increasing automation for the quantitative and systematic assessment of left ventricular (LV) dysfunction. The study is designed to achieve the following three objectives.\n\nThe primary objective is to develop a convolutional neural network (CNN)-based deep learning model for the automatic segmentation of the LV endocardial contour throughout the cardiac cycle using intracavitary MRI data. To support model training, a dataset of LV endocardial wall segmentations will be generated from balanced steady-state free precession (bSSFP) images. A purpose-built retrospective MRI database of bSSFP images will be retrieved to accelerate training set creation.\n\nThe secondary objective is to develop a numerical framework for non-invasive MRI-based pressure-volume (PV) loop reconstruction and calculation of simplified hemodynamic force descriptors (HDFs). A prospective cohort of patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) will be enrolled. Pre-procedural non-contrast 4D Flow MRI will be acquired, and non-invasive MRI-derived PV loops will be quantitatively compared with invasive catheter-based PV loop measurements. In addition, simplified HDFs will be compared with 4D Flow-derived HDFs to assess their agreement and their potential to elucidate specific features of heart failure-related LV dysfunction.\n\nThe tertiary objective is to establish the foundation for a unified, standalone, and clinically deployable framework for comprehensive, automated, and clinician-friendly analysis of LV hemodynamics based on 4D Flow MRI. Internal testing, benchmarking, and structured evaluation by clinical end-users with prior 4D Flow MRI research experience will be conducted to collect feedback and guide further development and clinical translation.",[482,483,484],"Left Ventricle Function","Transcatheter Aortic Valve Replacement (TAVR)","Aortic Valve Stenosis",[486],"4D Flow MRI","2026-03-02",{"date":489,"type":37},"2026-03-06",{"date":491,"type":37},"2025-10-13",{"date":493,"type":22},"2026-09-30",{"name":43,"class":44},{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":505,"conditions":506,"keywords":513,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":45},"100623863","the-signature-of-alzheimers-disease-in-subjective-cognitive-decline-100623863","NCT07402161","The Signature of Alzheimer's Disease in Subjective Cognitive Decline","Unraveling the SIGNature of ALzheimer's Disease: Integrating Multimodal Biomarkers Through Machine Learning","SIGN-AL","Inclusion Criteria:\n\n* Clinical diagnosis of SCD according to the SCD-I criteria;\n* Mini-Mental State Examination (MMSE) score greater than 24, adjusted for age and education level;\n* Normal functioning on the Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) scales.\n\nExclusion Criteria:\n\n* History of head trauma;\n* Current neurological and\u002For systemic diseases;\n* Symptoms of psychosis, major depression, or substance use disorder.",{"count":504,"type":22},250,"This study focuses on improving early detection of Alzheimer's disease (AD) in patients with subjective cognitive decline (SCD), a preclinical stage of cognitive impairment, in the context of emerging disease-modifying therapies (DMTs). Current biomarkers, such as brain MRI, PET scans, and cerebrospinal fluid (CSF) markers, are highly accurate but costly, invasive, and not widely accessible.\n\nThe study aims to provide cost-effective, scalable tools for early identification of individuals at risk, enabling personalized assessment and timely DMT administration.\n\nObjectives:\n\n* Evaluate the accuracy of innovative, easily accessible biomarkers in predicting biologically confirmed AD.\n* Assess the predictive utility of previously studied methods for SCD patients.\n* Explore new approaches, including automated speech analysis, to identify cognitive decline.\n* Evaluate genetic contributions to AD risk.\n* Integrate data from these various modalities using machine learning to create a predictive model for AD in SCD patients.\n\nStudy Design:\n\nThis is a multicenter, longitudinal, low-intervention study conducted at IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (UO1) and the Center for Research and Innovation in Dementia, Careggi Hospital, Florence, Italy (UO2). Eligible participants are adults with SCD, intact daily functioning, and Mini-Mental State Examination (MMSE) scores \\>24. Exclusion criteria include neurological or systemic diseases, major psychiatric disorders, substance use, or prior head injury.\n\nParticipants undergo:\n\n* Detailed medical and family history collection.\n* Comprehensive neuropsychological, personality, and independence in daily activities assessment\n* EEG recording in resting state.\n* Blood sampling for plasma biomarkers (Aβ42, Aβ40, p-tau181, p-tau217, t-tau, NfL, GFAP).\n* CSF biomarker analysis (Aβ42, Aβ40, p-tau, t-tau).\n* Genetic analysis of AD-related genes (PSEN1, PSEN2, APOE, TREM2, ABCA7, BDNF, HTT).\n* Speech recording and analysis using standardized tasks to extract features for automated evaluation.\n\nThe study expects to create a machine learning-based predictive model combining biomarker, neuropsychological, EEG, speech, and genetic data to improve early detection and guide personalized patient care.\n\nProcedures:\n\n* Neuropsychological evaluations occur at baseline and two-year follow-up.\n* Language recordings are conducted in controlled settings using standardized picture description tasks.\n* EEG is recorded using 21-channel systems.\n* Blood and CSF samples are collected, processed, and stored at -80°C for subsequent analysis at respective institutional laboratories.\n* Plasma biomarkers are analyzed with Simoa technology; CSF biomarkers are analyzed using chemiluminescent enzyme immunoassay (CLEIA).\n* Genetic analyses employ PCR, high-resolution melting analysis (HRMA), sequencing, and capillary electrophoresis as appropriate for specific genes or polymorphisms.\n\nThe study expects to create a machine learning-based predictive model combining biomarker, neuropsychological, EEG, speech, and genetic data to improve early detection and guide personalized patient care.",[507,508,509,510,511,512],"Subjective Cognitive Decline (SCD)","Subjective Cognitive Complaints (SCCs)","Subjective Cognitive Impairment","Subjective Cognitive Concerns","Subjective Memory Complaint","Subjective Memory Decline",[514,515,516,517,518,519],"Alzheimer","Neuropsychology","EEG","Machine Learning","Biomarkers","Speech","2026-02-03",{"date":522,"type":37},"2026-02-11",{"date":524,"type":37},"2025-10-01",{"date":526,"type":22},"2028-03-01",{"name":43,"class":44},{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":532,"acronym":533,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":18,"minAge":535,"maxAge":536,"enrollmentInfo":537,"targetDuration":539,"studyType":24,"phases":4,"briefSummary":540,"conditions":541,"keywords":543,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":45},"100623027","genetic-aortic-diseases-and-cardiovascular-complications-an-observational-survey-of-risk-factors-100623027","NCT07391293","Genetic Aortic Diseases and Cardiovascular Complications. An Observational Survey of Risk Factors.","PROM-1","Inclusion Criteria:\n\n* signed onformed consent\n* Ability to speak, read and write in Italian\n\nExclusion Criteria:\n\n\\-","14 Years","60 Years",{"count":538,"type":22},208,"15 Months","The aim of this observational study is to define the behavioural and cardiovascular risk factor profiles of patients with genetic aortopathies. The main questions it aims to answer are:\n\n* How do the interconnections between lifestyle, stress, psychological condition, perception of illness, and state of health influence each other in this population?\n* Beyond traditional risk factors, additional emerging factors should be considered, including pregnancy-related complications, sedentary lifestyle, early menopause and depression. The interplay between eating disorders, lifestyle factors and autoimmune or inflammatory bowel diseases remains poorly understood.",[542],"Thoracic Aortic Aneurysm (TAA)",[544,545,546,547],"risk stratification","quality of life","rare disease","survey","2026-01-29",{"date":550,"type":37},"2026-02-05",{"date":552,"type":37},"2025-05-06",{"date":554,"type":22},"2027-05",{"name":43,"class":44},{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":562,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":564,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":45},"100622534","ai-based-shape-and-function-analysis-of-mitral-valve-prolapse-using-3d-ultrasound-100622534","NCT07384871","AI-Based Shape and Function Analysis of Mitral Valve Prolapse Using 3D Ultrasound","AI-Based Morphological Analysis and Biomechanical Numerical Evaluation of Mitral Valve Prolapse (MVP) From Real-Time 3D Echocardiography (RT3DE)","AI4MVP","Inclusion Criteria:\n\n* Adult patients (age \\> 18 years old);\n* Documented symptomatic degenerative MR with indication to MVP surgical repair, following the Heart Team decision;\n* Periprocedural transesophageal 3DRTE of the MV apparatus, which is clinical standard modality for morphological assessment and guidance during MVP surgical repair;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Inadequate quality of 3DRTE imaging, e.g., due to inadequate patient-specific acoustic window;\n* 3DRTE imaging with a temporal resolution of \\\u003C 20 Hz;\n* Patient treated through prosthetic MV replacement.",{"count":565,"type":22},150,"This study aims to develop and validate a fully automated imaging and modeling pipeline for the analysis of mitral valve prolapse (MVP) using real-time three-dimensional transesophageal echocardiography (RT3DE). The primary goal is to automatically segment mitral valve (MV) substructures, extract anatomical landmarks, and generate 3D models of the MV apparatus to characterize morphological and functional features of degenerative MVP. Advanced deep learning techniques and geometric processing tools will be applied to enable automated analysis.\n\nA secondary objective is to build patient-specific finite element (FE) models based on RT3DE data to evaluate the biomechanical consequences of MVP and to simulate the effects of surgical repair. These simulations will assess stress distribution and force transmission within the MV apparatus.\n\nAdditionally, in cases where substantial surgical resection of MV tissue occurs, excised leaflet samples will be collected and preserved for histological and morphometric analysis.",[568,569],"Mitral Valve Prolapse","Myxomatous Mitral Valve Degeneration","2026-01-26",{"date":520,"type":37},{"date":573,"type":37},"2025-05-26",{"date":575,"type":22},"2028-05",{"name":43,"class":44},{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":111,"phases":585,"briefSummary":586,"conditions":587,"keywords":4,"overallStatus":319,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":599,"locationsCount":45},"100620979","analysis-of-the-presence-and-cardiac-functional-effects-of-anti-nav15-autoantibodies-in-patients-with-metastatic-tumors-100620979","NCT07364656","Analysis of the Presence and Cardiac Functional Effects of Anti-NaV1.5 Autoantibodies in Patients With Metastatic Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients with a confirmed diagnosis of breast or colorectal cancer, either metastatic or non-metastatic\n* Patients already receiving first-line therapy with a confirmed diagnosis of breast or colorectal cancer, either metastatic or non-metastatic\n* Signed informed consent\n\nExclusion Criteria:\n\n* Clinically significant cardiovascular diseases (atrial fibrillation, congestive heart failure, cardiomyopathies, or inherited arrhythmic syndromes)\n* Known autoimmune diseases or immunodeficiencies\n* Use of high-dose immunosuppressive drugs or other experimental treatments that could interfere with the assessment of study endpoints",{"count":584,"type":22},196,[113],"The overall aim of this study is to identify and characterize anti-NaV1.5 autoantibodies in patients with metastatic breast and colorectal cancer. These tumors are characterized by the presence of a specific target structure (called nNaV1.5) against which antibodies are produced. These antibodies may cross-react with a similar structure (called NaV1.5) that is found in the heart. This could affect channel function and increase the risk of arrhythmias.",[588,589,590,591,592],"Brugada Syndrome (BrS)","Breast Cancer Females","Colon Cancer","ECG Abnormalities","Autoantibodies Screening","2026-01-16",{"date":595,"type":37},"2026-01-23",{"date":597,"type":22},"2026-01",{"date":382,"type":22},{"name":43,"class":44},{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":108,"sex":18,"minAge":608,"maxAge":609,"enrollmentInfo":610,"targetDuration":4,"studyType":111,"phases":612,"briefSummary":613,"conditions":614,"keywords":616,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":627},"100580080","novel-risk-prediction-approaches-for-the-primary-prevention-of-cardiovascular-diseases-in-italy-the-cvrisk-it-trial-cvrisk-it-100580080","NCT06832644","Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial (CVRISK-IT)","Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial","CVRISK-IT","Inclusion Criteria:\n\n* Age: 40-80 years\n* Apparently healthy individuals without previous medical history of CVD or diabetes (based on medical diagnosis)\n* Participant recruitment arranged only at selected IRCCS (and associated Spokes) as part of the 'Rete Cardiologica'\n* Participants must have signed the Informed Consent and Data Privacy Treatment forms\n* Participants must have a personal e-mail address and internet connection\n\nExclusion Criteria:\n\n* Age ≤40 or ≥80 years\n* Individuals have previous medical history related to CVD (e.g., heart failure, congenital heart disorder, coronary heart disease) based on medical diagnosis\n* Candidates have previously participated in clinical studies of 'Rete Cardiologica' (e.g., PREVITAL)\n* Medical diagnosis of mental disorders\n* Pregnancy based on self-reported information\n* Previous history of type 1 or type 2 diabetes (based on medical diagnosis)\n* Oncology patients (based on physician indication)","40 Years","80 Years",{"count":611,"type":22},30000,[113],"The CVRISK-IT study aims to evaluate the health benefit of measuring genetic and imaging risk information in men and women considered at 'low-to-moderate' or 'high' risk of developing cardiovascular diseases (CVD) in a randomized controlled trial in Italian primary care settings. Our primary objective is to answer a fundamental question in the prevention and prediction of CVD in Italy and globally: is there any benefit in including additional information (such as genetic and\u002For imaging data) in estimating risk, in conjunction with lifestyle advice and medical treatment for primary prevention of CVD?\n\nAs a key secondary objective of the CVRISK-IT study, the goal is to build a large bioresource with clinical information and biological samples to facilitate a new generation of discovery and translational research that will advance understanding of the genetic, molecular and behavioural determinants as well as mechanisms of multiple chronic diseases in the Italian population. By contributing to the Rete Cardiologica database and the BBDCARDIO biobank, the CVRISK-IT study will also serve as a cornerstone for future investigations into the development and testing of early diagnostic technologies and preventive (or 'personalised precision health') interventions for chronic diseases.",[308,615],"Genetic Cardiovascular Risk",[617,308,618],"Primary Prevention","SCORE2\u002F2-OP","2026-01-12",{"date":621,"type":37},"2026-01-14",{"date":623,"type":37},"2025-01-22",{"date":625,"type":22},"2030-01-01",{"name":43,"class":44},17,{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":634,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":636,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":638,"conditions":639,"keywords":641,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":45},"100598774","the-artemis-data-collection-study-100598774","NCT07075861","The ARTEMIS Data Collection Study","JenaValve Trilogy for Patients With Pure Native Aortic Valve Rigurgitation: the ARTEMIS Data Collection Study","ARTEMIS","Inclusion Criteria:\n\n* Considered at high or prohibitive risk for surgical aortic valve replacement by the Heart Team\n\n  * 18 years of age or older\n  * Suitable anatomy according to the IFU\n  * Absence of significant disease of the ascending aorta, including ascending aortic aneurysm (defined as maximal luminal diameter of 50mm or greater) or atheroma (especially if thick \\[\\>5mm\\], protruding or ulcerated)\n\nExclusion Criteria:\n\nThe JenaValve Trilogy Heart Valve System is contraindicated for use in patients who have known hypersensitivity or contraindication to Nitinol (titanium and\u002For nickel), an anti-coagulation\u002Fanti-platelet regimen or contrast medium that cannot be managed with premedication, or who have active bacterial endocarditis or other active infections.\n\nThe JenaValve Trilogy Heart Valve System is contraindicated in those patients whose anatomy does not accommodate the System due to anatomical considerations outlined in the inclusion criteria.",{"count":637,"type":22},75,"To observe the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with evere native aortic regurgitation (AR) who are indicated for TAVR Data collection",[640],"Aortic Regurgitation Disease",[642,643,30],"JenaValve Trilogy","Aortic Regurgitation","2025-12-17",{"date":646,"type":37},"2025-12-24",{"date":648,"type":37},"2025-08-10",{"date":650,"type":22},"2028-08-10",{"name":43,"class":44},{"id":653,"slug":654,"hasResults":12,"nctId":655,"briefTitle":656,"officialTitle":657,"acronym":658,"eligibilityCriteria":659,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":660,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":661,"conditions":662,"keywords":666,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":45},"100494209","aortic-stiffness-in-patients-with-genetic-aortopathies-100494209","NCT05715203","Aortic Stiffness in Patients With Genetic Aortopathies","Aortic Stiffness in Patients With Genetic Aortopathies: Intervention Analysis","PULSEWAVE","Inclusion Criteria:\n\n* Subjects with AAT, either syndromic or non syndromic;\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients with early menopause and\u002For osteoporosis, rheumatic heart disease and active malignant tumours;\n* Patients with acute and chronic inflammatory conditions such as: chronic liver disease, chronic renal insufficiency and diseases affecting the thyroid system;\n* Seropositivity to HIV, HCV, HBsAg and SARS-CoV-2;\n* Pregnancy",{"count":504,"type":22},"The goal of this observational study is to study arterial stiffness in patients with thoracic ascending aortic aneurysms (TAA), either syndromic or non-syndromic. The main questions it aims to answer are:\n\n* Stratification of aortic risk based on arterial stiffness; Compare measurements with morphological and haemodynamic features of the ascending thoracic aorta.\n\nParticipants will be asked to undergo non-invasive evaluation of blood pressure and arterial stiffness.",[663,664,665],"Rare Diseases","Aortic Stiffness","Connective Tissue Defect",[667,668,669],"arterial stiffness","Ascending aortic aneurysm","pulse wave velocity","2025-09-08",{"date":672,"type":37},"2025-09-10",{"date":674,"type":37},"2023-02-15",{"date":676,"type":22},"2025-12-31",{"name":43,"class":44},""]