Status:
UNKNOWN
MYocarditis and/or Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study
Lead Sponsor:
Cardiology Research UBC
Conditions:
Myocarditis
Myocarditis Acute
Eligibility:
All Genders
Brief Summary
Myocarditis is inflammation of the heart muscle. Pericarditis is inflammation of the lining surrounding the heart muscle. Symptoms of these conditions can include pain in the chest and rapid or irregu...
Eligibility Criteria
Inclusion
- Inclusion criteria for vaccine associated myocarditis/pericarditis.
- COVID-19 vaccination within previous 42 days. AND
- At least one cardiac symptom of suspected myocarditis/pericarditis (Appendix 5).
- OR At least two non-specific symptoms (Appendix 5). OR In infants and young children, at least two non-specific pediatric symptoms (Appendix 5).
- OR No symptoms, but abnormal histopathology or a combination of abnormal cardiac biomarkers with abnormal cardiac imaging (echo or MRI).
- AND
- At least one of the following objective findings (Brighton Criteria case definitions, Appendices 1 to 5):
- Histopathologic examination of myocardial tissue (autopsy or endomyocardial biopsy) showed myocardial inflammation.
- Elevated myocardial biomarker (Troponin T, Troponin I, or CK-MB).
- Cardiac MRI abnormality.
- Echocardiographic abnormality.
- New or worsening arrhythmia on electrocardiogram, Holter monitor, or telemetry.
- Elevated inflammation biomarkers: erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), hs-CRP, or D-Dimer.
- Physical examination pericardial friction rub or pulsus paradoxus.
- Pericardial fluid or inflammation by imaging (echo, MRI, or CT).
- Enlarged heart on chest radiograph.
- AND
- No alternative cause of presentation. e.g. infectious or autoimmune myocarditis.
- Inclusion criteria for COVID-19 associated myocarditis/pericarditis
- COVID-19 infection within the previous 42 days.
- AND
- Myocarditis/pericarditis as per Brighton Criteria for vaccine associated myocarditis/pericarditis.
- AND
- No alternative cause of presentation.
- Inclusion criteria alternative etiology myocarditis.
- Myocarditis/pericarditis as per Brighton Criteria for vaccine associated myocarditis/pericarditis.
- AND
- No alternative cause of presentation.
Exclusion
- For prospective invitation and follow-up, inability to provide informed consent. Consent will be sought from patients or their authorised substitute decision maker.
- Patients not fulfilling Brighton Criteria levels 1-3 will be excluded if they are level 4 (insufficient evidence for myocarditis) or Level 5 (not myocarditis) or have an alternative diagnosis such as myocardial infarction.
Key Trial Info
Start Date :
April 23 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 23 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06103123
Start Date
April 23 2023
End Date
April 23 2025
Last Update
October 26 2023
Active Locations (1)
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1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9