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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myocarditis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute myocarditis<br>Patients hospitalized for an acute myocarditis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiac events | Defined as a composite of : All cause death Resuscitated cardiac arrest Heart transplant Longterm mechanical circulatory support Ventricular arrhythmia after discharge Hospitalization for heart failure Hospitalization for myocarditis recurrence | up to 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiac events | Defined as a composite of : All cause death Resuscitated cardiac arrest Heart transplant Longterm mechanical circulatory support Ventricular arrhythmia after discharge Hospitalization for heart failure Hospitalization for myocarditis recurrence | up to 20 years | 
| All cause death |  | up to 20 years | 
| Cardiovascular death |  | up to 20 years | 
| Heart transplant | Number of patients with heart transplant | up to 20 years | 
| Sustained ventricular arrhythmia after discharge | Number of patients with sustained ventricular arrhythmia after discharge | up to 20 years | 
| Resuscitated cardiac arrest | Number of patients with resuscitated cardiac arrest | up to 20 years | 
| Longterm mechanical circulatory support | Number of patients implanted with a longterm mechanical circulatory support | up to 20 years | 
| Hospitalization for myocarditis recurrence | Number of patients hospitalized for myocarditis recurrence | up to 20 years | 
| Hospitalization for heart failure | Number of patients with hospitalization for heart failure | up to 20 years | 
| Pericardial drainage | Number of patients with a surgery of pericardial drainage | up to 20 years | 
| Supra ventricular arrythmia | Number of patients with a new onset of supra ventricular arrhythmia | up to 20 years | 
| High grade atrioventricular block | Number of patients with a new high grade atrioventricular block | up to 20 years | 
| Pericarditis | Number of patients with pericarditis diagnosed by the patient referring physician's | up to 20 years | 
| Left ventricular systolic function under 50% | Evaluated by transthoracic echocardiography | up to 20 years | 
| Therapeutics during hospital stay | Type and duration of therapeutics received during the initial hospital stay | From the day of admission up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Viral, Cardiomyopathies, Inflammatory heart disease, Magnetic resonance imaging