NCT07717073

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
602

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Jul 2025Jan 2027

Study Start

First participant enrolled

July 15, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

June 11, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

acute myocarditispathogenic genetic variantsdilated cardiomyopathiescardiomyopathiesarrhythmogenic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • All-cause mortality

    From index hospitalization for acute myocarditis up to 10 years of follow-up (including SNDS linkage when available)

  • Cardiovascular mortality

    From index hospitalization for acute myocarditis up to 10 years of follow-up (including SNDS linkage when available)

  • Major adverse cardiovascular events

    During index hospitalization and up to 10 years of follow-up (via SNDS linkage and medical records)

  • Cardiac MRI sequelae

    During follow-up imaging performed as part of routine clinical care, up to 10 years after index myocarditis episode

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients included in myocarditIRM who have genetic data

You may qualify if:

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

You may not qualify if:

  • Patient who has objected to the reuse of their data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Poitiers

Poitiers, France, 86000, France

Location

MeSH Terms

Conditions

Cardiomyopathy, DilatedCardiomyopathies

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2026

First Posted

July 21, 2026

Study Start

July 15, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

July 21, 2026

Record last verified: 2026-07

Locations