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Myocarditis After SARS-CoV2-Vaccination

Myocarditis After SARS-CoV2-Vaccination: An International Patient Registry on Clinical Manifestations and Outcomes

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05268458
Acronym
MYOVACC
Enrollment
100
Registered
2022-03-07
Start date
2021-11-12
Completion date
2022-06-30
Last updated
2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocarditis and Cardiomyopathy

Keywords

SARS CoV-19, Vaccination

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
Combined Primary Endpoint6 monthsDeath, Hospitalization, symptomatic Heart Failure

Countries

Germany

Contacts

Primary ContactMarco Ochs, MD
m.ochs@theresienkrankenhaus.de49621/424-4268

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026