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

NCT ID: NCT04844151

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-23
• Study Completion Date: 2041-05-01

Brief Summary

The AMPHIBIA study is an observational ambispective and prospective cohort that aim to describe the histologic, immunologic, biological, imaging, genetic and clinical characteristics of the patients hospitalized for an acute myocarditis and to evaluate their association with prognosis.

Detailed Description

Acute myocarditis is an inflammatory disease of the heart muscle. Its clinical presentation and its etiologies are multiple and make it a complex disease to treat. Its course also varies, ranging from complete clinical recovery to recurrence of ventricular arrhythmia or progression to chronic dilated heart disease, while being difficult to predict. The long-term prognosis is poorly understood.

Consecutive patients hospitalized in a tertiary university referral center cohort from 2006 to 2041 for an acute myocarditis will be ambispectively or prospectively analyzed. This project will establish a registry including up to 400 patients in the ambispective analysis cohort from 2006 to 2021 and 1000 patients in the prospective analysis cohort during a 20 years inclusion period.

The aim of the study is to describe the characteristics of patients hospitalized for an acute myocarditis and to evaluate their association wih the long term (until 20 years) prognosis.

Features of interest will include :

• Clinical
• Biological
• Etiological
• Echocardiographic
• Cardiac magnetic resonance imaging
• Genetics (for the prospective cohort)
• Anatomopathological

The collection of clinical, biological and radiological data will represent an unique source allowing research teams in the coming years to access the data necessary to answer various specific questions (pathophysiological, diagnostic, prognostic) relevant to the state of knowledge on this pathology.

Conditions

Myocarditis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Acute myocarditis

Patients hospitalized for an acute myocarditis.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Acute myocarditis confirmed by cardiac magnetic resonance according to Lake Louise modified criteria or by endomyocardial biopsy according to histologic, immunologic and immunohistochemic criteria.
• affiliation to the French Health Care System "Sécurité sociale"

Exclusion Criteria

• Severe valvulopathy
• Complex congenital cardiopathy
• Previous heart transplant
• Known significative coronary disease

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giles MONTALESCOT, MD, PhD

Role: STUDY_DIRECTOR

ACTION Study Group - Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Pitié-Salpêtrière

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Mathieu Kerneis, MD

Role: CONTACT

mathieu.kerneis@aphp.fr

+33142163001

Facility Contacts

Mathieu KERNEIS, MD

Role: primary

mathieu.kerneis@aphp.fr

0142163001

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Other Identifiers

APHP201197

Identifier Type: -

Identifier Source: org_study_id