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

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

This study is trying to see how mRNA COVID-19 vaccines might affect heart health by following patients who develop heart inflammation after getting vaccinated.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Sex: All
• Sponsor: Cardiology Research UBC (Academic / other)
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT06103123 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals who have received an mRNA COVID-19 vaccine within the last 42 days and exhibit symptoms or objective findings indicative of myocarditis or pericarditis.

Not a fit: Patients who have not received an mRNA COVID-19 vaccine or do not exhibit any symptoms or objective findings related to myocarditis or pericarditis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the cardiovascular effects of mRNA COVID-19 vaccines, potentially guiding safer vaccination practices.

How similar studies have performed: Other studies have explored myocarditis and pericarditis in relation to COVID-19 vaccination, indicating a growing body of evidence on this topic.

Eligibility criteria

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 this trial is running

Vancouver, British Columbia

• Vancouver General Hospital — Vancouver, British Columbia, Canada (Recruiting)

Study contacts

• Principal investigator: Nathaniel Hawkins, MD — Vancouver General Hospital
• Study coordinator: Jenny Petterson, MSc

Conditions Myocarditis; Myocarditis Acute; Pericarditis; Pericarditis Acute