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

Recruiting

• Conditions: Pericarditis; Myocarditis; Myocarditis Acute; Pericarditis Acute
• Interventions: Diagnostic Test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire; Other: Baseline Quality of Life questionnaire

• Registration Number: NCT06103123
• Lead Sponsor: Cardiology Research UBC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-23
• Study First Submitted: 2023-05-29
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-24
• Last Update Submitted: 2023-10-24
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26
• Primary Completion: 2025-03-23
• Study Completion: 2025-04-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 infection associated pericarditis	Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire	Participants who had developed pericarditis within 42 days of being infected with the SARS-COV-2 virus
mRNA COVID-19 vaccine associated myocarditis	Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire	Participants who had developed myocarditis within 42 days of getting a mRNA COVID-19 vaccine
mRNA COVID-19 vaccine associated pericarditis	Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire	Participants who had developed pericarditis within 42 days of getting a mRNA COVID-19 vaccine
COVID-19 infection associated myocarditis	Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire	Participants who had developed myocarditis within 42 days of being infected with the SARS-COV-2 virus
Alternative etiology myocarditis	Baseline Quality of Life questionnaire	Any participants with myocarditis that is not associated with the mRNA COVID-19 vaccine or SARS-COV-2 viral infection

Primary Outcome Measures

Name	Time	Method
Recovery of cardiac function in patients with previously documented abnormal cardiac function	Through study completion, an average of 3 years	Patients with Left Ventricular Ejection Fraction (LVEF)\<55% during anytime at baseline, with LVEF increase by 5% from worst baseline measurement
Depression and anxiety using validated instruments at baseline, 3 months, 12 months, and annually	Through study completion, an average of 3 years	Depression and anxiety data: PHQ-9 and GAD-7.
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)	From date of vaccination and up to 3 years	Including any of: * Death from any cause.; * Ventricular arrhythmia (ventricular fibrillation or ventricular tachycardia).; * Heart block (type II or type III block).; * Heart failure (national guideline criteria).; * Left ventricular systolic dysfunction (left ventricular ejection fraction \[LVEF\] \<55%).; * Cardiac tamponade.
Quality of life using validated instruments at baseline, 3 months, 12 months, and annually	Through study completion, an average of 3 years	Quality of life: EQ-5D-5L questionnaire for adults or EQ-5D-Y questionnaire for children.
Physical activity using validated instruments at baseline, 3 months, 12 months, and annually	Through study completion, an average of 3 years	Physical activity: International Activity Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Rate of atrial arrhythmias after mRNA COVID-19 vaccination?	From date of vaccination for up to three years
Individual components of primary composite endpoint at 30 days and 42 days post mRNA COVID-19 vaccination?	From date of vaccination for up to three years
Rate of recurrence of myocarditis/pericarditis after mRNA COVID-19 vaccination?	From date of vaccination for up to three years
Rate of all-cause and cardiovascular mortality after mRNA COVID-19 vaccination?	From date of vaccination for up to three years
Rate of all-cause and cardiovascular hospitalization after mRNA COVID-19 vaccination?	From date of vaccination for up to three years
Rate of constrictive pericarditis after mRNA COVID-19 vaccination?	From date of vaccination for up to three years

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada