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MYOVACC: Myocarditis After SARS-CoV2-Vaccination

Sponsor
Theresien Hospital Mannheim (Other)
Overall Status
Recruiting
CT.gov ID
NCT05268458
Collaborator
University Hospital Heidelberg, GER (Other), GRN Hospital Weinheim, GER (Other), McGill University Health Care Montreal, CA (Other), Foothills Medical Centre Calgary, CA (Other), Sunnybrooks Research Institute Toronto, CA (Other), Unity Health St. Michael's Hospital Toronto, CA (Other)
100
Enrollment
1
Location
6.6
Anticipated Duration (Months)
15.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background The novel coronavirus disease 2019 (COVID-19) caused by an infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly become a global pandemic with more than 190.000.000 infections and 4.250.000 reported deaths worldwide.

SARS-CoV-2 vaccination plays an important role in containing the pandemic and the possible adverse complications of COVID-19. Large clinical trials have proven the safety and efficacy of the vaccines currently in use. Systemic reactions usually were mild, self-limiting and could be observed more often in younger vaccine recipients. Cases of myocarditis after vaccination have been reported for various vaccines. The new vaccines for SARS-CoV-2 also seem to be affected by this adverse reactions. The pathophysiology is uncertain so far.

Aim Aim of this study is a systematic registration of myocarditis cases associated with SARS-CoV-2 vaccination which were diagnosed and/or treated in participating centers. The main goal of this study is the characterization of clinical manifestations and prognosis of the disease.

Study Design Patient history, laboratory tests and cardiovascular imaging data of patients with suspected SARS-CoV-2 - vaccine associated myocarditis are documented. Patients with clinical suspicion of troponin-positive myocarditis within 30 days after receiving SARS-CoV-2 vaccine without evidence for apparent other causes e.g. infectious or autoimmune etiology were included. Clinical follow-up data is acquired.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Myocarditis After SARS-CoV2-Vaccination: An International Patient Registry on Clinical Manifestations and Outcomes
    Actual Study Start Date :
    Nov 12, 2021
    Anticipated Primary Completion Date :
    Mar 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Combined Primary Endpoint [6 months]

      Death, Hospitalization, symptomatic Heart Failure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • SARS-CoV-2 Vaccine-associated Myocarditis (< 30 days after vaccination) confirmed by cardiac MRI without evidence of alternative etiology (infectious, auto-immune myocarditis).
    Exclusion Criteria:
    • missing individual consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Theresienkrankenhaus Mannheim Baden Württemberg Germany 65168

    Sponsors and Collaborators

    • Theresien Hospital Mannheim
    • University Hospital Heidelberg, GER
    • GRN Hospital Weinheim, GER
    • McGill University Health Care Montreal, CA
    • Foothills Medical Centre Calgary, CA
    • Sunnybrooks Research Institute Toronto, CA
    • Unity Health St. Michael's Hospital Toronto, CA

    Investigators

    • Principal Investigator: Marco Ochs, MD, Theresien Hospital Mannheim

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marco Ochs, Attending, Cardiologist, Theresien Hospital Mannheim
    ClinicalTrials.gov Identifier:
    NCT05268458
    Other Study ID Numbers:
    • TKH-032022-001
    First Posted:
    Mar 7, 2022
    Last Update Posted:
    Mar 7, 2022
    Last Verified:
    Mar 1, 2022
    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 Marco Ochs, Attending, Cardiologist, Theresien Hospital Mannheim
    SARS CoV-19
    Vaccination
    Additional relevant MeSH terms:
    Cardiomyopathies
    Myocarditis

    Study Results

    No Results Posted as of Mar 7, 2022