Incidence, Patient Characteristics and Outcome of Myocarditis After COVID-19 mRNA Vaccine
Condition: Myocarditis
MeSH terms: COVID-19; Myocarditis
Study type: Observational

Summary: 
      This study evaluates the incidence, patient characteristics and outcome of myocarditis after
      the COVID-19 mRNA vaccination in healthcare professionals.
    

Detailed description: 
      Considering previous reports of cardiovascular adverse events, passive surveillance might not
      identify all myocarditis/myopericarditis cases after COVID-19 vaccination and it is possible
      that a mild/subclinical myocarditis might be much more prevalent in the population. This
      research project has three aims: first, provide novel insights regarding the incidence,
      patient characteristics and outcome of myocarditis. Second, provide a safety net by active
      surveillance for myocarditis, allowing early initiation of appropriate therapy. Third,
      provide reassurance to the public regarding myocarditis, as questions have been raised by
      critics of the pharmaceutical industry that Phase III studies performed by the pharmaceutical
      industry may have not appropriately captured adverse events.

      This study is screening persons undergoing the COVID-19 mRNA booster vaccination of possible
      development of myocarditis. This approach in detecting myocarditis would help early
      initiation of the right treatment under close monitoring of the clinical course. Furthermore,
      this kind of study might also help understand the development of myocarditis and possibly the
      reasons for sex differences. Myocarditis suspicion is raised when patients present symptoms
      of acute chest discomfort, myalgia, fever/chills, abnormal ECG, increased concentrations of
      high-sensitivity cardiac troponin T (hs-cTnT), possibly supported by signs of cardiac
      inflammation in cMRI (myocardial oedema, myocardial/pericardial late gadolinium enhancement,
      pericardial effusion). Since the study is performed on health care professionals working in
      the University Hospital Basel, it is able to monitor more closely the possible side effects
      of the mRNA vaccination. Consecutive individuals that received a COVID-19 mRNA vaccine
      booster and undergo a systematic approach to detect myocarditis at the University Hospital
      Basel will be included.
    

Intervention name(s): data collection in healthcare professionals with COVID-19 mRNA vaccine booster
Intervention type(s): Other
Intervention description(s): 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.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive individuals that received a COVID-19 mRNA vaccine booster and undergo a
        systematic approach to detect myocarditis at the University Hospital Basel will be
        included. The project population includes mainly healthcare workers, aged between 16-65.
      
Keywords: Major Adverse Cardiac Events (MACE); COVID-19 vaccination; Comirnaty (Pfizer/BioNTech) mRNA vaccine; Moderna mRNA vaccine; myopericarditis; health care professionals; COVID-19 booster vaccination; vaccination-induced myocarditis