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RAM: Recurrent Acute Myocarditis Registry

Sponsor
University Hospital, Caen (Other)
Overall Status
Recruiting
CT.gov ID
NCT04589156
Collaborator
(none)
20
Enrollment
1
Location
48
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The association between myocardial inflammation (clinically represented by acute myocarditis episodes) and the later development of an arrhythmogenic cardiomyopathy is widely elusive.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Acute myocarditis (AM) is an inflammatory disease of the myocardium caused by different infectious and non-infectious triggers. It is a major cause of sudden cardiac death, with also long-term adverse outcomes in survivors. The incidence and predictive factors of recurrent AM (RAM) are unknown.

    Arrhythmogenic cardiomyopathy (ACM) is a genetically-determined or acquired arrhythmogenic disorder of the myocardium. With an incidence of 1/5000, genetic ACM is the consequence of pathogenic variants in genes encoding for desmosomal and cytoskeleton proteins. Originally described as a right ventricular disease (ARVC), genetic ACM is increasingly recognized as a left (ALVC) or biventricular entity. Genetic ACM may manifest with various clinical presentations, with a predisposition to acute and chronic heart failure, ventricular arrhythmias and sudden cardiac death. Pathophysiology of genetic ACM at early stages remain widely elusive.

    Myocardial inflammation has been consistently reported in patients with genetic ACM, but the exact nature of their association is a matter of debate. The temporal association between RAM episodes and the later diagnosis of genetic ACM is speculative, and it has been hypothesized recently that RAM episodes might reflect early active phases in the development of a genetic ACM.

    The investigators aim to study the temporal association between RAM episodes and the later diagnosis of an ACM.

    Consecutive patients with at least two episodes of AM and referred to a tertiary university referral center (pop. 1.500.000 inhabitants) for clinical expertise, follow-up and etiological work-out were prospectively included in this registry.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Recurrent Acute Myocarditis : Characteristics, Etiology, Prognosis and Genetic Basis.
    Actual Study Start Date :
    Jan 1, 2018
    Anticipated Primary Completion Date :
    Jan 1, 2022
    Anticipated Study Completion Date :
    Jan 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Sustained ventricular arrhythmia [0 - 1 year after last acute myocarditis episode]

      Any ventricular arrhythmia (VT/VF) : sustained (lasting more than 30 seconds) symptomatic or not (including sudden cardiac arrest) induced or not (including during stress ECG, pharmacological challenge or electrophysiological study)

    2. Genetic mutation [0 - 1 year after last acute myocarditis episode]

      Any genetic mutation (cardiomyopathy panel)

    Secondary Outcome Measures

    1. Myocardial substrate characterization [0 - 1 year after last acute myocarditis episode]

      Cardiac magnetic resonance imaging (left and right ventricular ejection fractions, volumes, late gadolinium enhancement)

    2. Nonsustained ventricular arrhythmia [0 - 1 year after last acute myocarditis episode]

      Any ventricular arrhythmia (VT/VF) : nonsustained (lasting less than 30 seconds) symptomatic or not induced or not (including during stress ECG, pharmacological challenge or electrophysiological study)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: patients with at least two episodes of acute myocarditis as defined by the European Society of Cardiology diagnostic criteria.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Caen University Hospital Caen Normandy France F-14000

    Sponsors and Collaborators

    • University Hospital, Caen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Hospital, Caen
    ClinicalTrials.gov Identifier:
    NCT04589156
    Other Study ID Numbers:
    • Rythmo20200818
    First Posted:
    Oct 19, 2020
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Caen
    Recurrent acute myocarditis
    Myocardial inflammation
    Arrhythmogenic cardiomyopathy
    Additional relevant MeSH terms:
    Cardiomyopathies
    Myocarditis

    Study Results

    No Results Posted as of Oct 19, 2020