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

A

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Myocarditis

Study type

Observational

Funder types

Other

Identifiers

NCT04844151
APHP201197

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,400 estimated patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,400 participants in 1 patient group

Acute myocarditis
Description:
Patients hospitalized for an acute myocarditis.

Trial contacts and locations

1

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Central trial contact

Mathieu Kerneis, MD

Data sourced from clinicaltrials.gov

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