Acute Myocarditis Registry With Prognostic, Histologic, Immunologic, Biological, Imaging and Clinical Assessment
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-06-06
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What this Trial Is About
Researchers are conducting the AMPHIBIA study, an observational cohort focusing on patients hospitalized with acute myocarditis, an inflammatory disease of the heart muscle. This study aims to describe the clinical, biological, imaging, genetic, and histologic features of these patients and how these relate to their long-term prognosis. The study includes both retrospective and prospective analysis, covering patients from 2006 up to 2041 to better understand this complex condition and its outcomes.
Patients hospitalized with acute myocarditis will have their clinical, biological, etiological, echocardiographic, cardiac magnetic resonance imaging, genetic (for prospective patients), and anatomopathological data collected and analyzed. The registry will include up to 400 patients in the retrospective cohort and 1000 patients in the prospective cohort over 20 years. This comprehensive data collection will support research into the disease's diagnosis, prognosis, and underlying mechanisms.
Participants will undergo various assessments including clinical evaluations, imaging scans, biological tests, and genetic analyses as appropriate. Researchers will monitor major cardiac events over one year as the primary outcome and track long-term outcomes such as death, heart transplant, arrhythmias, heart failure, and other cardiac events for up to 20 years. This extensive follow-up aims to provide a detailed understanding of acute myocarditis and its progression over time.
CONDITIONS
Brief Title
Acute Myocarditis Registry With Prognostic, Histologic, Immunologic, Biological, Imaging and Clinical Assessment
Who Can Participate
Age: 15Years +
All Genders
Eligibility Criteria
You may qualify if you...
Acute myocarditis confirmed by cardiac magnetic resonance according to Lake Louise modified criteria or by endomyocardial biopsy using histologic, immunologic, and immunohistochemical criteria
Affiliated with the French Health Care System (S�curit� sociale)
Age 15 years or older
You will not qualify if you...
Severe valvular heart disease
Complex congenital heart disease
Previous heart transplant
Known significant coronary artery disease
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - From hospital admission up to 90 days
Participants undergo diagnostic assessments including clinical, biological, echocardiographic, cardiac magnetic resonance imaging, and histologic evaluation to confirm acute myocarditis.
Hospital visits during hospital stay and assessments up to 90 days
Long-term Monitoring
Duration - Up to 20 years
Participants are followed up to observe long-term outcomes such as cardiac events, death, heart transplant, arrhythmias, and heart failure.
Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013.
Ongoing enterovirus-induced myocarditis is associated with persistent heart muscle infection: quantitative analysis of virus replication, tissue damage, and inflammation.
2011 consensus statement on endomyocardial biopsy from the Association for European Cardiovascular Pathology and the Society for Cardiovascular Pathology.
Ornella Leone, John P Veinot, Annalisa Angelini...