- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07394543
French Registry of CMR Late Gadolinium Enhancement in Myocarditis (MYOCARDITI-LGE)
January 30, 2026 updated by: Assistance Publique - Hôpitaux de Paris
Retrospective French Registry of Cardiovascular Magnetic Resonance Late Gadolinium Enhancement in Patients With Myocarditis
Acute myocarditis is a major cause of death in young adults and carries substantial morbidity, including a significant risk of progression to dilated cardiomyopathy.
Current diagnostic and therapeutic strategies remain poorly defined, making risk stratification crucial to enable personalized treatments and reduce mortality and major cardiovascular events.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Théo PEZEL, Dr
- Phone Number: +33 6 68 72 24 89
- Email: theo.pezel@aphp.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study will include all consecutive patients with AM referred for CMR assessment.
Description
Inclusion Criteria:
- Age ≥ 18 years
- Ability to provide informed non-opposition
- AM diagnosis confirmed using CMR, fulfilling the modified Lake Louise diagnostic criteria
Exclusion Criteria:
1. Patients unable to provide informed non-opposition.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All-cause mortality
Time Frame: From enrollment to the end of follow up at 10 years
|
All-cause mortality defined using the French national registry of death (INSEE).
|
From enrollment to the end of follow up at 10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
All-cause death
Time Frame: From enrollment to the end of follow up at 10 years
|
From enrollment to the end of follow up at 10 years
|
|
Heart transplantation
Time Frame: From enrollment to the end of follow up at 10 years
|
From enrollment to the end of follow up at 10 years
|
|
Ventricular arrhythmia
Time Frame: From enrollment to the end of follow up at 10 years
|
From enrollment to the end of follow up at 10 years
|
|
Hospitalisation for acute heart failure
Time Frame: From enrollment to the end of follow up at 10 years
|
From enrollment to the end of follow up at 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 10, 2026
Primary Completion (Estimated)
February 10, 2036
Study Completion (Estimated)
February 10, 2036
Study Registration Dates
First Submitted
January 30, 2026
First Submitted That Met QC Criteria
January 30, 2026
First Posted (Actual)
February 6, 2026
Study Record Updates
Last Update Posted (Actual)
February 6, 2026
Last Update Submitted That Met QC Criteria
January 30, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP251399
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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