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

Cardiology Research UBC

Status: Enrolling

Conditions: Pericarditis; Myocarditis; Myocarditis Acute; Pericarditis Acute

Treatments: Other: Baseline Quality of Life questionnaire; Diagnostic Test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT06103123

MYCOVACC

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 5 patient groups

mRNA COVID-19 vaccine associated myocarditis

Description:

Participants who had developed myocarditis within 42 days of getting a mRNA COVID-19 vaccine

Treatment:

Diagnostic Test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire

mRNA COVID-19 vaccine associated pericarditis

Description:

Participants who had developed pericarditis within 42 days of getting a mRNA COVID-19 vaccine

Treatment:

Diagnostic Test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire

COVID-19 infection associated myocarditis

Description:

Participants who had developed myocarditis within 42 days of being infected with the SARS-COV-2 virus

Treatment:

Diagnostic Test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire

COVID-19 infection associated pericarditis

Description:

Participants who had developed pericarditis within 42 days of being infected with the SARS-COV-2 virus

Treatment:

Diagnostic Test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire

Alternative etiology myocarditis

Description:

Any participants with myocarditis that is not associated with the mRNA COVID-19 vaccine or SARS-COV-2 viral infection

Treatment:

Other: Baseline Quality of Life questionnaire