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| Name | Class |
|---|---|
| University Hospital Heidelberg | OTHER |
| GRN Hospital Weinheim, GER | UNKNOWN |
| McGill University Health Care Montreal, CA | UNKNOWN |
| Foothills Medical Centre Calgary, CA |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Combined Primary Endpoint | Death, Hospitalization, symptomatic Heart Failure | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with SARS-CoV-2 Vaccine-associated Myocarditis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Ochs, MD | Contact | 49621/424-4268 | m.ochs@theresienkrankenhaus.de |
| Name | Affiliation | Role |
|---|---|---|
| Marco Ochs, MD | Theresien Hospital Mannheim | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Theresienkrankenhaus | Recruiting | Mannheim | Baden-Wurttemberg | 65168 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37416926 | Derived | Schroth D, Garg R, Bocova X, Hansmann J, Haass M, Yan A, Fernando C, Chacko B, Oikonomou A, White J, Alhussein MM, Giusca S, Ochs A, Korosoglou G, Andre F, Friedrich MG, Ochs M. Predictors of persistent symptoms after mRNA SARS-CoV-2 vaccine-related myocarditis (myovacc registry). Front Cardiovasc Med. 2023 Jun 21;10:1204232. doi: 10.3389/fcvm.2023.1204232. eCollection 2023. |
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| ID | Term |
|---|---|
| D009205 | Myocarditis |
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| UNKNOWN |
| Sunnybrooks Research Institute Toronto, CA | UNKNOWN |
| Unity Health St. Michael's Hospital Toronto, CA | UNKNOWN |
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