Incidence, Patient Characteristics and Outcome of Myocarditis After COVID-19 mRNA Vaccine

CompletedOBSERVATIONAL
Enrollment

835

Participants

Timeline

Start Date

December 10, 2021

Primary Completion Date

April 20, 2022

Study Completion Date

April 20, 2022

Conditions
Myocarditis
Interventions
OTHER

data collection in healthcare professionals with COVID-19 mRNA vaccine booster

Day 3 (48 - 96h) post COVID-19 mRNA booster: data collection on symptoms (chest pain, dyspnea, myalgia, fever, chills); blood sample for cardiomyocyte injury (hs-cTnT, hs-cTnI). If elevated hs-cTnT concentration, participant has to avoid strenuous exercise. Work-up on Day 4: clinical evaluation, ECG, 2. blood sampling for hs-cTnT. If hs-cTnT \> 100 ng/l, cardiac magnetic resonance imaging is done for signs of cardiac inflammation. If hs-cTnT rises above upper limit but doesn't exceed 100 ng/l, clinical exam might be evaluated. In confirmed myocarditis, a clinical assessment (treatment, need for hospitalization, length of rhythm monitoring, rest) is evaluated by a cardiologist. Day 4: EDTA blood from all subjects with elevated troponin at day 3 post-vaccination is collected for pathomechanism of mRNA vaccine associated myocarditis. 1-month follow-up: questionnaire on predefined cardiac endpoints.

Trial Locations (1)

4031

University Hospital Basel, Department of Cardiology, Basel

All Listed Sponsors
lead

University Hospital, Basel, Switzerland

OTHER

NCT05438472 - Incidence, Patient Characteristics and Outcome of Myocarditis After COVID-19 mRNA Vaccine | Biotech Hunter | Biotech Hunter