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RECRUITING

NCT06103123

MYocarditis and/or Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study

Sponsor: Cardiology Research UBC

View on ClinicalTrials.gov

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 irregular heartbeat. There are many different causes for myocarditis and pericarditis including COVID-19 infection. The MYCOVACC study will identify patients using local screening strategies, including research communications, care provider referrals, and medical record review. The retrospective component of the study will collect information about patients suffering from vaccine associated myopericarditis and COVID-19 associated myopericarditis. Consenting patients will then be prospectively followed according to standard of care protocols. The main objectives of MYCOVACC are to describe the rate of major adverse cardiovascular events, functional outcomes including quality of life, and myocardial recovery through imaging.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2023-04-23

Completion Date

2027-04-23

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Myocarditis Myocarditis Acute Pericarditis Pericarditis Acute

Interventions

DIAGNOSTIC_TEST

Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire

Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire will be used to follow the clinical outcomes and patient reported outcomes to assess for study objectives

OTHER

Baseline Quality of Life questionnaire

Only baseline quality of life questionnaires will be utilized in the alternative etiology myocarditis cohort as they will not be followed up in the study

Inclusion Criteria: * Inclusion criteria for vaccine associated myocarditis/pericarditis. 1. COVID-19 vaccination within previous 42 days. AND 2. 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 3. At least one of the following objective findings (Brighton Criteria case definitions, Appendices 1 to 5): 1. Histopathologic examination of myocardial tissue (autopsy or endomyocardial biopsy) showed myocardial inflammation. 2. Elevated myocardial biomarker (Troponin T, Troponin I, or CK-MB). 3. Cardiac MRI abnormality. 4. Echocardiographic abnormality. 5. New or worsening arrhythmia on electrocardiogram, Holter monitor, or telemetry. 6. Elevated inflammation biomarkers: erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), hs-CRP, or D-Dimer. 7. Physical examination pericardial friction rub or pulsus paradoxus. 8. Pericardial fluid or inflammation by imaging (echo, MRI, or CT). 9. Enlarged heart on chest radiograph. AND 4. No alternative cause of presentation. e.g. infectious or autoimmune myocarditis. * Inclusion criteria for COVID-19 associated myocarditis/pericarditis 1. COVID-19 infection within the previous 42 days. AND 2. Myocarditis/pericarditis as per Brighton Criteria for vaccine associated myocarditis/pericarditis. AND 3. No alternative cause of presentation. Inclusion criteria alternative etiology myocarditis. 1. Myocarditis/pericarditis as per Brighton Criteria for vaccine associated myocarditis/pericarditis. AND 2. No alternative cause of presentation. Exclusion Criteria: * 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.

Locations (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada