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Myocarditis After SARS-CoV2-Vaccination

NCT05268458 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-03-07

No results posted yet for this study

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.

Conditions

  • Myocarditis and Cardiomyopathy

Sponsors & Collaborators

  • University Hospital Heidelberg, GER

    collaborator UNKNOWN

  • GRN Hospital Weinheim, GER

    collaborator UNKNOWN

  • McGill University Health Care Montreal, CA

    collaborator UNKNOWN

  • Foothills Medical Centre Calgary, CA

    collaborator UNKNOWN

  • Sunnybrooks Research Institute Toronto, CA

    collaborator UNKNOWN

  • Unity Health St. Michael's Hospital Toronto, CA

    collaborator UNKNOWN

  • Theresien Hospital Mannheim

    lead OTHER

Principal Investigators

  • Marco Ochs, MD · Theresien Hospital Mannheim

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-12
Primary Completion
2022-03-31
Completion
2022-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05268458 on ClinicalTrials.gov