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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04844151
Collaborator
(none)
1,400
240

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Acute Myocarditis Registry With Prognostic, Histologic, Immunologic, Biological, Imaging and Clinical Assessment
    Anticipated Study Start Date :
    May 1, 2021
    Anticipated Primary Completion Date :
    May 1, 2041
    Anticipated Study Completion Date :
    May 1, 2041

    Arms and Interventions

    Arm Intervention/Treatment
    Acute myocarditis

    Patients hospitalized for an acute myocarditis.

    Outcome Measures

    Primary Outcome Measures

    1. Major cardiac events [up to 1 years]

      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

    Secondary Outcome Measures

    1. Major cardiac events [up to 20 years]

      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

    2. All cause death [up to 20 years]

    3. Cardiovascular death [up to 20 years]

    4. Heart transplant [up to 20 years]

      Number of patients with heart transplant

    5. Sustained ventricular arrhythmia after discharge [up to 20 years]

      Number of patients with sustained ventricular arrhythmia after discharge

    6. Resuscitated cardiac arrest [up to 20 years]

      Number of patients with resuscitated cardiac arrest

    7. Longterm mechanical circulatory support [up to 20 years]

      Number of patients implanted with a longterm mechanical circulatory support

    8. Hospitalization for myocarditis recurrence [up to 20 years]

      Number of patients hospitalized for myocarditis recurrence

    9. Hospitalization for heart failure [up to 20 years]

      Number of patients with hospitalization for heart failure

    10. Pericardial drainage [up to 20 years]

      Number of patients with a surgery of pericardial drainage

    11. Supra ventricular arrythmia [up to 20 years]

      Number of patients with a new onset of supra ventricular arrhythmia

    12. High grade atrioventricular block [up to 20 years]

      Number of patients with a new high grade atrioventricular block

    13. Pericarditis [up to 20 years]

      Number of patients with pericarditis diagnosed by the patient referring physician's

    14. Left ventricular systolic function under 50% [up to 20 years]

      Evaluated by transthoracic echocardiography

    15. Therapeutics during hospital stay [From the day of admission up to 90 days]

      Type and duration of therapeutics received during the initial hospital stay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Study Director: Giles MONTALESCOT, MD, PhD, ACTION Study Group - Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT04844151
    Other Study ID Numbers:
    • APHP201197
    First Posted:
    Apr 14, 2021
    Last Update Posted:
    Apr 14, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 14, 2021