Clinical trial NCT06103123: MYocarditis and/or Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study
Official title: MYocarditis and/or Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocarditis
Myocarditis Acute
Pericarditis
Pericarditis Acute
Lead sponsor: Cardiology Research UBC
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have suffered or are suffering from 1) COVID-19 infection associated myocarditis, 2) COVID-19 infection associated pericarditis, 3) COVID-19 vaccine associated myocarditis, 4) COVID-19 vaccine associated pericarditis, 5) Alternative etiology myocarditis, 6) Alternative etiology pericarditis

Definition of myocarditis and pericarditis follows standard clinical definition as outlined in "Brighton Collaboration myocarditis case definition and levels of diagnostic certainty 1,2 and 3"

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 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.


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.

Primary outcomes:
measure: Composite Major Adverse Cardiac Event (MACE) at 30 days post vaccination (preferred by cardiovascular community) and at 42 days post vaccination (preferred by vaccine monitoring investigators)
timeFrame: From date of vaccination and up to 3 years
measure: Recovery of cardiac function in patients with previously documented abnormal cardiac function
timeFrame: Through study completion, an average of 3 years
measure: Quality of life using validated instruments at baseline, 3 months, 12 months, and annually
timeFrame: Through study completion, an average of 3 years
measure: Depression and anxiety using validated instruments at baseline, 3 months, 12 months, and annually
timeFrame: Through study completion, an average of 3 years
measure: Physical activity using validated instruments at baseline, 3 months, 12 months, and annually
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: Individual components of primary composite endpoint at 30 days and 42 days post mRNA COVID-19 vaccination?
timeFrame: From date of vaccination for up to three years
measure: Rate of atrial arrhythmias after mRNA COVID-19 vaccination?
timeFrame: From date of vaccination for up to three years
measure: Rate of all-cause and cardiovascular mortality after mRNA COVID-19 vaccination?
timeFrame: From date of vaccination for up to three years
measure: Rate of all-cause and cardiovascular hospitalization after mRNA COVID-19 vaccination?
timeFrame: From date of vaccination for up to three years
measure: Rate of recurrence of myocarditis/pericarditis after mRNA COVID-19 vaccination?
timeFrame: From date of vaccination for up to three years
measure: Rate of constrictive pericarditis after mRNA COVID-19 vaccination?
timeFrame: From date of vaccination for up to three years
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: Vancouver General Hospital
name: Nathaniel Hawkins, MD
role: PRINCIPAL_INVESTIGATOR
References: