Markers to Predict Sudden Cardiac Death Risk After MI with Moderate LVEF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective interventional study enrolled post-MI patients with LVEF between 35% and 50% at least 40 days after the infarct. All participants undergo cardiac MRI and additional evaluations, with a risk score based on the De Chillou score and other biomarkers assessed over a 60-month follow-up. The study uses an implantable loop recorder with remote monitoring to track arrhythmic events and SCD endpoints. A primary goal is to identify markers that contribute to a predictive risk model for sudden death and malignant arrhythmias. An auxiliary CE-marked implantable rhythm-monitoring device is used as part of the monitoring strategy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients over 18 years of age
* Hospitalized for acute STEMI within 6 months (Type 1 myocardial infarction according to ESC recommendations, Thygesen EHJ 2018).
* Left ventricular ejection fraction between 35% and 50% at least 40 days after acute myocardial infarction (see above).
* Under optimal tolerated medical treatment.
* Covered by a social security scheme.
* Legally competent to give voluntary informed consent to participate in the study.
* Patient who will not participate in further studies involving an investigational drug or device until the end of the trial (i.e. 60 months). Participation in registries is authorized

Exclusion Criteria:

* Presence of a secondary prevention indication for implantation of an implantable automatic defibrillator (ICD)
* Presence of a pacemaker
* Administration of ventricular antiarrhythmic drugs other than beta-blockers (i.e. amiodarone, sotalol, flecainide)
* Patients with systemic diseases (cancer, liver failure or end-stage renal disease)
* Patients with assessed life expectancy \< 1 year.
* Age \> 80
* Adult patient under legal protection (guardianship, curatorship or other legal protection measure)
* The subject is pregnant or nursing or positive beta HCG for women of childbearing age
* Patient participating in another clinical research protocol involving an investigational drug or device within the last 30 days (participation in a registry is permitted at the same time).

Where it's running

• CHU Bordeaux
  Bordeaux, France Recruiting
• CHRU Lille
  Lille, France Recruiting
• CHU Nantes Hôpital Nord Laennec
  Nantes, France Recruiting
• CHU Strasbourg
  Strasbourg, France Recruiting
• CHU Amiens
  Amiens, France Not yet recruiting
• CHU Brest
  Brest, France Not yet recruiting

Study contacts

• Principal investigator: Romain ESCHALIER — University Hospital, Clermont-Ferrand
• Study coordinator: Lise Laclautre
• Email: promo_interne_drci@chu-clermontferrand.fr
• Phone: +33473754963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.