MyocarditIRM-Génétique - Genetic Sub-study of the French Cohort of Acute Myocarditis Cases Diagnosed by MRI (MyocarditIRM-G)

The aim of this retrospective, non-interventional study is to assess the prevalence and describe the genetic variants found in a cohort of patients with acute myocarditis confirmed by MRI. This is a study linked to the MyocarditIRM cohort, designed to collect genetic test results obtained as part of routine clinical care.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Myocarditis

• Study Type: Observational
• Enrollment (Estimated): 602

Contacts and Locations

Study Locations

• France
  • France
    • Poitiers, France, France, 86000
      • CHU de Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients included in myocarditIRM who have genetic data

Description

Inclusion Criteria:

• Patient enrolled in MyocarditIRM
• Patient who has undergone genetic testing

Exclusion Criteria:

• Patient who has objected to the reuse of their data

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients included in Cohort MyocarditIRM with genetic testing results available; Retrospective observational study using data extracted from the hospital data warehouse and linked to the French National Health Data System (SNDS). Genetic analyses were performed as part of routine clinical care and were retrospectively collected for research purposes. No study-specific intervention was performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence and characterization of genetic variants (genes involved and ACMG classification) in patients with MRI-confirmed acute myocarditis.	From index hospitalization for acute myocarditis up to 10 years of follow-up (including SNDS linkage when available)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality during follow-up	From index hospitalization for acute myocarditis up to 10 years of follow-up (including SNDS linkage when available)
Cardiovascular mortality	Cardiovascular mortality during follow-up	From index hospitalization for acute myocarditis up to 10 years of follow-up (including SNDS linkage when available)
Major adverse cardiovascular events	Occurrence of major adverse cardiovascular events, including heart failure requiring hospitalization, newly diagnosed dilated cardiomyopathy not present prior to the myocarditis episode, ventricular arrhythmias, high-degree atrioventricular block, implantation of an implantable cardioverter-defibrillator (ICD), pacemaker, wearable cardioverter-defibrillator (life vest), or implantable loop recorder, recurrent myocarditis, and heart transplantation.	During index hospitalization and up to 10 years of follow-up (via SNDS linkage and medical records)
Cardiac MRI sequelae	Presence of myocardial sequelae on cardiac magnetic resonance imaging (MRI) during follow-up in patients who underwent follow-up imaging as part of routine clinical care	During follow-up imaging performed as part of routine clinical care, up to 10 years after index myocarditis episode

Collaborators and Investigators

• Sponsor: French Cardiology Society

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: cardiomyopathies; acute myocarditis; pathogenic genetic variants; dilated cardiomyopathies; arrhythmogenic
• Additional Relevant MeSH Terms: Laminopathies; Cardiovascular Diseases; Heart Diseases; Genetic Diseases, Inborn; Cardiomegaly; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: 2025-A01310-49 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No