Acute MyocarditisMyocarditIRM-GNCT07717073
MyocarditIRM-Génétique - Genetic Sub-study of the French Cohort of Acute Myocarditis Cases Diagnosed by MRI
An observational study of Acute Myocarditis, run by French Cardiology Society at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocarditis
- How many people
- 602 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients included in myocarditIRM who have genetic data
Who may be able to join
- Patient enrolled in MyocarditIRM
- Patient who has undergone genetic testing
Who cannot join
- Patient who has objected to the reuse of their data
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Acute Myocarditis
- Keywords
- acute myocarditis, pathogenic genetic variants, dilated cardiomyopathies, cardiomyopathies, arrhythmogenic
- Medical subject headings
- Cardiomyopathy, Dilated, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and characterization of genetic variants (genes involved and ACMG classification) in patients with MRI-confirmed acute myocarditis.
Measured: From index hospitalization for acute myocarditis up to 10 years of follow-up (including SNDS linkage when available)
Secondary outcomes (4)
All-cause mortality
All-cause mortality during follow-up
Measured: 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
Measured: 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.
Measured: 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
Measured: During follow-up imaging performed as part of routine clinical care, up to 10 years after index myocarditis episode
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start15 Jul 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute MyocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 602 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717073
- Sponsor's protocol ID
- 2025-A01310-49
- Other IDs
- 2025-A01310-49
- Acronym
- MyocarditIRM-G
- Status last verified
- Jul 2026
- First submitted
- 11 Jun 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyocarditIRM-Génétique - Genetic Sub-study of the French Cohort of Acute Myocarditis Cases Diagnosed by MRI
- ClinicalTrials.gov ID
- NCT07717073
- Acronym / sponsor ID
- MyocarditIRM-G / 2025-A01310-49
- Conditions
- Acute Myocarditis
- Keywords
- acute myocarditis, pathogenic genetic variants, dilated cardiomyopathies, cardiomyopathies, arrhythmogenic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 602 participants (estimated)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients included in myocarditIRM who have genetic data
Key inclusion criteria (2 listed)
- Patient enrolled in MyocarditIRM
- Patient who has undergone genetic testing
Key exclusion criteria (1 listed)
- Patient who has objected to the reuse of their data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence and characterization of genetic variants (genes involved and ACMG classification) in patients with MRI-confirmed acute myocarditis.
Time frame: From index hospitalization for acute myocarditis up to 10 years of follow-up (including SNDS linkage when available)
4 secondary outcomes
All-cause mortality
Time frame: From index hospitalization for acute myocarditis up to 10 years of follow-up (including SNDS linkage when available)
Cardiovascular mortality
Time frame: From index hospitalization for acute myocarditis up to 10 years of follow-up (including SNDS linkage when available)
Major adverse cardiovascular events
Time frame: During index hospitalization and up to 10 years of follow-up (via SNDS linkage and medical records)
Cardiac MRI sequelae
Time frame: During follow-up imaging performed as part of routine clinical care, up to 10 years after index myocarditis episode
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocarditis, run by French Cardiology Society at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and characterization of genetic variants (genes involved and ACMG classification) in patients with MRI-confirmed acute myocarditis. (time frame: From index hospitalization for acute myocarditis up to 10 years of follow-up (including SNDS linkage when available)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.