NCT06269692Not yet recruiting
MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators
Multicenter randomiSed Trial on MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators
Source: ClinicalTrials.gov · Last updated 21 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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). 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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1812 (estimated)
- First submitted
- 16 Jan 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 1 Apr 2030
- Lead sponsor
- Central Hospital, Nancy, France
- Diseases
- Coronary artery disease
- NCT number
- NCT06269692
What you commit to
- Study type: Interventional
- Planned participants: 1812
- From 1 Apr 2024 to the primary completion date, 1 Apr 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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);
Lab values
- Severe renal insufficiency defined by a glomerular filtration rate (GFR) \< 30 mL/min/1.73m²;
Age
- Woman of childbearing age without effective contraception;
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHRU Nancy Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.