[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536812":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":33,"locations":41,"responsibleParty":58,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":26,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":84,"overallStatus":85,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Central Hospital, Nancy, France","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Implantable Loop Recorder","EXPERIMENTAL","Patients identified at very low-risk of VT\u002FVF randomized to be implanted with an ILR (experimental strategy). Following randomization, these patients will be followed using remote ILR monitoring.",[13,14],"Device: MRI screening","Device: Implantable Loop Recorder",{"label":16,"type":6,"description":17,"interventionNames":18},"Implantable Cardioverter Defibrillator","Patients identified at very low-risk of VT\u002FVF randomized to be implanted with an ICD (reference strategy), which corresponds to the currently recommended treatment in post-MI patients with a LVEF ≤35% (European Society of Cardiology guidelines 2015) (Zeppenfeld et al., 2022).",[13,19],"Device: Implantable Cardioverter Defibrillator",[21,27,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","MRI screening","Cardiac Magnetic Resonance imaging for the quantification of the infarct intramural scar",[16,9],null,{"type":22,"name":9,"description":28,"armGroupLabels":29,"otherNames":26},"Inplantation of the Implantable Loop Recorder (ILR) for the patients assigned to the experimental group",[9],{"type":22,"name":16,"description":31,"armGroupLabels":32,"otherNames":26},"Inplantation of the Implantable Cardioverter Defibrillator (ICD) for the patients assigned to the control group, according to the current guidelines",[16],[34,38],{"name":35,"role":36,"phone":26,"phoneExt":26,"email":37},"Christian de CHILLOU, MD, PhD","CONTACT","c.dechillou@chru-nancy.fr",{"name":39,"role":36,"phone":26,"phoneExt":26,"email":40},"Guilaume DROUOT, PhD","g.drouot@chru-nancy.fr",[42],{"facility":43,"status":26,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"CHRU Nancy","Vandœuvre-lès-Nancy","54511","France","FR",{"type":49,"coordinates":50},"Point",[51,52],6.17114,48.66115,{"lat":52,"lon":51},[55,56],{"name":35,"role":36,"phone":26,"phoneExt":26,"email":37},{"name":57,"role":36,"phone":26,"phoneExt":26,"email":40},"Guillaume DROUOT, PhD",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Christian DE CHILLOU","Coordinating Investigator","100536812","magnetic-resonance-imaging-guided-implantation-of-cardioverter-defibrillators-100536812",false,"NCT06269692","MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators","Multicenter randomiSed Trial on MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators","SMART-DEF","Inclusion Criteria:\n\n* Age \\> 18 years;\n* Patients with a LVEF≤35% assessed at least after a 40 to 90 days period (depending on the presence of coronary revascularization) following an index myocardial infarction;\n* Left ventricular systolic impairment as defined by LVEF≤35% by any current standard technique (echocardiogram, multiple gated acquisition scan, or MRI) within 2 months;\n* Able and willing to comply with all pre-, post- and follow-up testing, and requirements;\n* Use of maximum tolerated doses of ACE inhibitors (or Angiotensin II Receptor Blockers if intolerant of ACE) and Beta Blockers and MRA as per ESC guidelines;\n* Person affiliated to or beneficiary of a social security plan\n* Person informed about study organization and having signed the informed consent\n\nExclusion Criteria:\n\n* History of cardiac arrest or sustained VT or VF unless within 48 hours of an acute myocardial infarction;\n* Standard contraindications for cardiac LGE-MRI;\n* Hypersensitivity to gadolinium-based contrast agent;\n* Currently implanted permanent pacemaker and\u002For ICD;\n* Patient refusal of ICD\u002FILR implantation;\n* Currently implanted permanent pacemaker and\u002For ICD;\n* Clinical indication for or Cardiac Resynchronization Therapy (CRT);\n* Severe renal insufficiency defined by a glomerular filtration rate (GFR) \\\u003C 30 mL\u002Fmin\u002F1.73m²;\n* Recent PTCA (within 30 days) or CABG (within 90 days);\n* Baseline NYHA functional class IV;\n* Contraindication for ICD implantation according to current guidelines;\n* Woman of childbearing age without effective contraception;\n* Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the French Public Health Code.","ALL","18 Years",{"count":73,"type":74},1812,"ESTIMATED","INTERVENTIONAL",[77],"NA","Implantable cardioverter-defibrillators (ICD) are currently recommended for the primary prevention of sudden cardiac death (SCD) in patients with a remote (\\>6 weeks) myocardial infarction (MI) and a low (≤35%) left ventricular ejection fraction (LVEF).\n\nVentricular tachycardia (VT) and\u002For ventricular fibrillation (VF), which are responsible for most SCDs, result from the presence of surviving myocytes embedded within fibrotic MI-scar. The presence of these surviving myocytes, as well as their specific arrhythmic characteristics, is not captured by LVEF. Hence, the use of LVEF as a unique risk-stratifier of SCD results in a low proportion (17 to 31%) of appropriate ICD device therapy at 2 years. Consequently, most patients with a prophylactic ICD do not present VT\u002FVF requiring ICD therapy prior to their first-ICD battery depletion. Thus, many patients are exposed to ICD complications, such as inappropriate shocks, without deriving any health benefit. Therefore, the current implantation strategy of prophylactic ICDs, based on LVEF only, needs to be improved in post-MI patients.",[80,81,82,83],"Myocardial Infarction","Ventricular Tachycardia","Ventricular Fibrillation","Sudden Cardiac Death",[80],"NOT_YET_RECRUITING","2024-02-19",{"date":88,"type":89},"2024-02-21","ACTUAL",{"date":91,"type":74},"2024-04-01",{"date":93,"type":74},"2030-04-01",{"name":5,"class":6},1]