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

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ClinicalTrials.gov Identifier: NCT04844151
Recruitment Status : Not yet recruiting
First Posted : April 14, 2021
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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
Myocarditis

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 20 Years
Official Title: Acute Myocarditis Registry With Prognostic, Histologic, Immunologic, Biological, Imaging and Clinical Assessment
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : May 1, 2041
Estimated Study Completion Date : May 1, 2041

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Acute myocarditis
Patients hospitalized for an acute myocarditis.


Outcome Measures
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Primary Outcome Measures :
  1. Major cardiac events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: up to 20 years ]
  3. Cardiovascular death [ Time Frame: up to 20 years ]
  4. Heart transplant [ Time Frame: up to 20 years ]
    Number of patients with heart transplant

  5. Sustained ventricular arrhythmia after discharge [ Time Frame: up to 20 years ]
    Number of patients with sustained ventricular arrhythmia after discharge

  6. Resuscitated cardiac arrest [ Time Frame: up to 20 years ]
    Number of patients with resuscitated cardiac arrest

  7. Longterm mechanical circulatory support [ Time Frame: up to 20 years ]
    Number of patients implanted with a longterm mechanical circulatory support

  8. Hospitalization for myocarditis recurrence [ Time Frame: up to 20 years ]
    Number of patients hospitalized for myocarditis recurrence

  9. Hospitalization for heart failure [ Time Frame: up to 20 years ]
    Number of patients with hospitalization for heart failure

  10. Pericardial drainage [ Time Frame: up to 20 years ]
    Number of patients with a surgery of pericardial drainage

  11. Supra ventricular arrythmia [ Time Frame: up to 20 years ]
    Number of patients with a new onset of supra ventricular arrhythmia

  12. High grade atrioventricular block [ Time Frame: up to 20 years ]
    Number of patients with a new high grade atrioventricular block

  13. Pericarditis [ Time Frame: up to 20 years ]
    Number of patients with pericarditis diagnosed by the patient referring physician's

  14. Left ventricular systolic function under 50% [ Time Frame: up to 20 years ]
    Evaluated by transthoracic echocardiography

  15. Therapeutics during hospital stay [ Time Frame: From the day of admission up to 90 days ]
    Type and duration of therapeutics received during the initial hospital stay


Biospecimen Retention:   Samples With DNA
Whole blood 20ml

Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients hospitalised at Pitié-Salpêtrière hospital (Paris, France) for an acute myocarditis.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04844151


Contacts
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Contact: Mathieu Kerneis, MD +33142163001 mathieu.kerneis@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Giles MONTALESCOT, MD, PhD ACTION Study Group - Assistance Publique - Hôpitaux de Paris
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04844151    
Other Study ID Numbers: APHP201197
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Cardiomyopathies
Inflammatory heart disease
Magnetic resonance imaging
Viral
Additional relevant MeSH terms:
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Myocarditis
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases