Actively Recruiting

Age: 15Years +
All Genders
ID04844151

Acute Myocarditis Registry With Prognostic, Histologic, Immunologic, Biological, Imaging and Clinical Assessment

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-06-06

1400

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

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

Eligible

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
Not Eligible

You will not qualify if you...

  • Severe valvular heart disease
  • Complex congenital heart disease
  • Previous heart transplant
  • Known significant coronary artery disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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.

Trial Site Locations

Total: 1 location

1

Hôpital Pitié-Salpêtrière

Paris, France, 75013

Actively Recruiting

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Research Team

M

Mathieu Kerneis, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

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.

Global Burden of Disease Study 2013 Collaborators

https://pubmed.ncbi.nlm.nih.gov/26063472

High prevalence of viral genomes and multiple viral infections in the myocardium of adults with "idiopathic" left ventricular dysfunction.

Uwe Kühl, Matthias Pauschinger, Michel Noutsias...

https://pubmed.ncbi.nlm.nih.gov/15699250

Ongoing enterovirus-induced myocarditis is associated with persistent heart muscle infection: quantitative analysis of virus replication, tissue damage, and inflammation.

K Klingel, C Hohenadl, A Canu...

https://pubmed.ncbi.nlm.nih.gov/1309611

Enteroviral infection of mice with severe combined immunodeficiency. Evidence for direct viral pathogenesis of myocardial injury.

L H Chow, K W Beisel, B M McManus

https://pubmed.ncbi.nlm.nih.gov/1309927

A prospective study of biopsy-proven myocarditis: prognostic relevance of clinical and aetiopathogenetic features at diagnosis.

Alida L P Caforio, Fiorella Calabrese, Annalisa Angelini...

https://pubmed.ncbi.nlm.nih.gov/17493945

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...

https://pubmed.ncbi.nlm.nih.gov/22137237