National surveillance of myocarditis and pericarditis after mRNA COVID-19 vaccination

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify and follow patients who develop myocarditis or pericarditis after receiving an mRNA COVID-19 vaccine. It employs local screening strategies, including referrals and medical record reviews, to collect data on patients experiencing vaccine-associated myocarditis and COVID-19 related myocarditis. The study will retrospectively gather information on these patients and then prospectively monitor their health outcomes, focusing on major adverse cardiovascular events, quality of life, and myocardial recovery through imaging techniques. The findings will help understand the implications of vaccination on heart health.

Why it matters

Who can join: the full rules

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.

Where it's running

• Vancouver General Hospital
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Nathaniel Hawkins, MD — Vancouver General Hospital
• Study coordinator: Jenny Petterson, MSc
• Email: jenny.petterson@vch.ca
• Phone: 604-875-5104

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.