An interventional study of Gadolinium-enhanced cardiac MRI in Acute STEMI and Severe Left Ventricular Systolic Dysfunction (Disorder), sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Diagnostic
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.
This 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.
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.
Many 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).
However, 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.
The 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.
Patients 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.
Initial 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.
Ratio of final ICD implantation will then be compared to the MRI criterion to determine whether LV recovery could have been predicted.
850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.
This study's enrollment of 12 is below the median of 194 across 527 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Early stages post-STEMI (within the first 5 days)
Other: Gadolinium-enhanced cardiac MRI
Gadolinium-enhanced cardiac MRI during the 1st days post-STEMI with specific sequences including extra-cellular volume measurement
Mesure of zones of delayed myocardial transmural enhancement and no-reflow
Defining the area at risk with Cardiac MRI
Time frame: 40 days
Mesure of ejection fraction and regional wall motion and thickening
Defining the area at risk with Cardiac MRI
Time frame: 40 days
Mesure of extracellular volume
Defining the area at risk with Cardiac MRI
Time frame: 40 days
Number of CVD events
Occurrence of major adverse cardiac events
Time frame: 40 days
Number of admission to the hospital for heart failure event
Occurrence of heart failure events
Time frame: 40 days
Number of ischemic cardiovascular events
Occurrence of major adverse cardiac events
Time frame: 40 days
Number of cardiac death
Occurrence of major adverse cardiac events
Time frame: 40 days
Plan to share: No
Ran from Jan 2019 to primary completion in Feb 2021, 25 months.
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This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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