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Testing MRI scans to guide defibrillator implantation in heart attack patients

Tests whether MRI scans can guide defibrillator implantation in adults after a heart attack.

Key facts

Who runs it
Central Hospital, Nancy, France
Where
Vandœuvre-lès-Nancy, FranceSee the site
Trial code
Registry title
MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators
Status
Not yet recruiting
People taking part
1,812 people, planned
Started
1 Apr 2024
Expected to end
1 Apr 2030
Type of study
Interventional, 2 groups
Treatments tested
  • MRI screening
  • Implantable Loop Recorder
  • Implantable Cardioverter Defibrillator
Record updated
21 February 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had a heart attack some weeks earlier and still have a weak heart pumping function (LVEF 35% or lower). It tests an MRI scan to guide who gets a defibrillator.

Age
Over 18 years
Sex
All sexes
Disease stage
Weak heart pumping (LVEF 35% or lower) at least 40 to 90 days after a heart attack, depending on whether the heart arteries were reopened. LVEF must be measured within 2 months.
Earlier treatment
Must take the highest dose they can tolerate of ACE inhibitors (or angiotensin II receptor blockers if ACE inhibitors are not tolerated), beta blockers and MRA, as set by ESC guidelines. Must not already have a pacemaker or defibrillator.
Biomarker or test result
LVEF 35% or lower on echocardiogram, multiple gated acquisition scan or MRI.

Main reasons for not taking part

  • Past cardiac arrest or sustained VT or VF (unless within 48 hours of a heart attack)
  • Cannot have a heart MRI with contrast, or allergic to gadolinium contrast
  • Already has a pacemaker or defibrillator, or needs cardiac resynchronization therapy
  • Severe kidney problems (GFR below 30 mL/min/1.73m²)
  • Recent PTCA (within 30 days) or CABG (within 90 days), or NYHA class IV

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • Age > 18 years
  • 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
  • Left ventricular systolic impairment as defined by LVEF≤35% by any current standard technique (echocardiogram, multiple gated acquisition scan, or MRI) within 2 months
  • Able and willing to comply with all pre-, post- and follow-up testing, and requirements
  • 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
  • Person affiliated to or beneficiary of a social security plan
  • Person informed about study organization and having signed the informed consent

Who cannot take part

  • History of cardiac arrest or sustained VT or VF unless within 48 hours of an acute myocardial infarction
  • Standard contraindications for cardiac LGE-MRI
  • Hypersensitivity to gadolinium-based contrast agent
  • Clinical indication for or Cardiac Resynchronization Therapy (CRT)
  • Severe renal insufficiency defined by a glomerular filtration rate (GFR) < 30 mL/min/1.73m²
  • Woman of childbearing age without effective contraception
  • Currently implanted permanent pacemaker and/or ICD
  • Patient refusal of ICD/ILR implantation
  • Currently implanted permanent pacemaker and/or ICD
  • Recent PTCA (within 30 days) or CABG (within 90 days)
  • Baseline NYHA functional class IV
  • Contraindication for ICD implantation according to current guidelines
  • Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the French Public Health Code

Where in France

  • CHRU NancyVandœuvre-lès-Nancy, FranceContact: Christian de CHILLOU, MD, PhDNo longer taking part

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

Ventricular tachycardia (VT) and/or 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/VF 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.

The 2 groups in the trial

  • Implantable Loop RecorderTreatment being tested

    Patients identified at very low-risk of VT/VF randomized to be implanted with an ILR (experimental strategy). Following randomization, these patients will be followed using remote ILR monitoring.

    Treatment: MRI screening and Implantable Loop Recorder

  • Implantable Cardioverter DefibrillatorOther group

    Patients identified at very low-risk of VT/VF 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).

    Treatment: MRI screening and Implantable Cardioverter Defibrillator

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Multicenter randomiSed Trial on MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators
Plain-language title
Testing MRI scans to guide defibrillator implantation in heart attack patientsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
21 February 2024