Myocarditis After SARS-CoV2-Vaccination

• Conditions: Myocarditis and Cardiomyopathy

• Registration Number: NCT05268458
• Lead Sponsor: Theresien Hospital Mannheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-12
• Status Verified: 2022-03
• Primary Completion: 2022-03
• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-03
• Last Update Submitted: 2022-03-03
• Study First Posted: 2022-03-07
• Last Update Posted: 2022-03-07
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined Primary Endpoint	6 months	Death, Hospitalization, symptomatic Heart Failure

Trial Locations

Locations (1)

Theresienkrankenhaus; 🇩🇪 Mannheim, Baden Württemberg, Germany