Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT03743935
Status:
TERMINATED
Last Update Posted:
2025-09-30
First Post:
2018-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Cardiac MRI in Early Stages of STEMI to Predict Left Ventricular Function Recovery and ICD Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D003645', 'term': 'Death, Sudden'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D003643', 'term': 'Death'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Recruitment difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2018-11-09', 'studyFirstSubmitQcDate': '2018-11-13', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mesure of zones of delayed myocardial transmural enhancement and no-reflow', 'timeFrame': '40 days', 'description': 'Defining the area at risk with Cardiac MRI'}, {'measure': 'Mesure of ejection fraction and regional wall motion and thickening', 'timeFrame': '40 days', 'description': 'Defining the area at risk with Cardiac MRI'}, {'measure': 'Mesure of extracellular volume', 'timeFrame': '40 days', 'description': 'Defining the area at risk with Cardiac MRI'}], 'secondaryOutcomes': [{'measure': 'Number of CVD events', 'timeFrame': '40 days', 'description': 'Occurrence of major adverse cardiac events'}, {'measure': 'Number of admission to the hospital for heart failure event', 'timeFrame': '40 days', 'description': 'Occurrence of heart failure events'}, {'measure': 'Number of ischemic cardiovascular events', 'timeFrame': '40 days', 'description': 'Occurrence of major adverse cardiac events'}, {'measure': 'Number of cardiac death', 'timeFrame': '40 days', 'description': 'Occurrence of major adverse cardiac events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['STEMI', 'MRI', 'ICD', 'Sudden death'], 'conditions': ['Acute STEMI', 'Severe Left Ventricular Systolic Dysfunction (Disorder)']}, 'referencesModule': {'references': [{'pmid': '3782318', 'type': 'BACKGROUND', 'citation': 'Tangerman A. Determination of volatile sulphur compounds in air at the parts per trillion level by Tenax trapping and gas chromatography. J Chromatogr. 1986 Sep 24;366:205-16. doi: 10.1016/s0021-9673(01)93468-5.'}, {'pmid': '21112897', 'type': 'BACKGROUND', 'citation': 'Perazzolo Marra M, Lima JA, Iliceto S. MRI in acute myocardial infarction. Eur Heart J. 2011 Feb;32(3):284-93. doi: 10.1093/eurheartj/ehq409. Epub 2010 Nov 25.'}, {'pmid': '25146709', 'type': 'BACKGROUND', 'citation': 'Schelbert EB, Wong TC. Imaging the area at risk in myocardial infarction with cardiovascular magnetic resonance. J Am Heart Assoc. 2014 Aug 21;3(4):e001253. doi: 10.1161/JAHA.114.001253. No abstract available.'}, {'pmid': '27899132', 'type': 'BACKGROUND', 'citation': 'Haaf P, Garg P, Messroghli DR, Broadbent DA, Greenwood JP, Plein S. Cardiac T1 Mapping and Extracellular Volume (ECV) in clinical practice: a comprehensive review. J Cardiovasc Magn Reson. 2016 Nov 30;18(1):89. doi: 10.1186/s12968-016-0308-4.'}, {'pmid': '28886621', 'type': 'BACKGROUND', 'citation': 'Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Patients presenting with STEMI and late revascularization can suffer from severe left ventricular dysfunction. Midterm and longterm mortality can be determined by the risk of fatal ventricular arrythmias. For this specific population, ESC guidelines currently recommend a waiting period of up to 40 days after a STEMI with severe left ventricular dysfunction before considering ICD implantation for primary prevention of sudden death.This delay is allocated to judge left ventricular recovery.\n\nThis study aims to see whether early cardiac MRI with specific sequences can help predict which patients will most probably not recover their left ventricular function and benefit from earlier ICD implantation.', 'detailedDescription': 'ST segment elevation myocardial infarction represent 120 000 annual cases in France. Although its mortality has been drastically reduced by primary percutaneous coronary angioplasty (PCI), its midterm and longterm outcome in patients presenting initially with severe left ventricular (LV) dysfunction depends on the risks of heart failure and sudden death by malignant ventricular arrhythmias.\n\nMany clinical studies such as MADIT I and II, MUSTT and DINAMIT have participated in defining which patients should benefit from ICD implantation. These studies were based on evaluation of the LV ejection fraction (LVEF) and of the risk of arrhythmia (by electrophysiology or holter recordings).\n\nHowever, ESC Guidelines recommend a mandatory waiting period of 40 days post-PCI to reevaluate LVEF before confirming the need for ICD implantation (LVEF \\< 35%). Therefore, patients are at risk of sudden cardiac death (SCD). during this period.\n\nThe investigators sought to determine whether specific cardiac MRI sequences could help predict which patients would eventually recover from their LV dysfunction and therefore reduce the risk of SCD by implanting ICD earlier than recommended.\n\nPatients presenting at our Cardiac ICU with STEMI and severe LV dysfunction (LVEF \\< 35%), not indicated to coronary artery bypass surgery (CABG) and free from initial cardiac arrest or severe ventricular arrhythmias, will be included. They will undergo a gadolinium-enhanced cardiac MRI during the 1st days of hospitalization with specific sequences to determine myocardial zones at risk of non-recovery.\n\nInitial assessment will also include thorough clinical examination with NYHA class, trans-thoracic echocardiography and blood works to evaluate renal function, inflammation, signs of heart failyre (BNP and troponin). Patients will be equipped with Lifevests for 6 weeks and followed-up with the same criteria.\n\nRatio of final ICD implantation will then be compared to the MRI criterion to determine whether LV recovery could have been predicted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute STEMI within 5 last days with LVEF \\< 35%\n* 18-80 years old\n* Admitted to the Cardiac ICU\n* Consent form\n\nExclusion Criteria:\n\n* CABG surgery indicated\n* Contra-indications to MRI\n* ICD or PPM in place\n* Follow-up compromised'}, 'identificationModule': {'nctId': 'NCT03743935', 'acronym': 'STEMI-MR', 'briefTitle': 'Use of Cardiac MRI in Early Stages of STEMI to Predict Left Ventricular Function Recovery and ICD Implantation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Primary Prevention ICD Implantation in STEMI With Severe Left Ventricular Dysfunction : Input of Early Cardiac MRI in Order to Predict Left Ventricular Recovery', 'orgStudyIdInfo': {'id': 'RECHMPL18_0183'}, 'secondaryIdInfos': [{'id': '2018-A02470-55', 'type': 'REGISTRY', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early cardiac MRI post-STEMI', 'description': 'Early stages post-STEMI (within the first 5 days)', 'interventionNames': ['Other: Gadolinium-enhanced cardiac MRI']}], 'interventions': [{'name': 'Gadolinium-enhanced cardiac MRI', 'type': 'OTHER', 'description': 'Gadolinium-enhanced cardiac MRI during the 1st days post-STEMI with specific sequences including extra-cellular volume measurement', 'armGroupLabels': ['Early cardiac MRI post-STEMI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34090', 'city': 'Montpellier', 'country': 'France', 'facility': 'University Hospital of Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Société Française de Cardiologie', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}