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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocarditis; Pericarditis; Myocarditis Acute; Pericarditis Acute
• Intervention / Treatment: Diagnostic test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire; Other: Baseline Quality of Life questionnaire

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Jenny Petterson, MSc; Phone Number: 604-875-5104; Email: jenny.petterson@vch.ca
• Study Contact Backup: Name: Naomi Uchida, RN; Phone Number: 604-875-5324; Email: naomi-uchida@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Recruiting
      • Vancouver General Hospital
      • Contact: Jenny Petterson, MSc; Phone Number: 604 - 875 - 5104; Email: jenny.petterson@vch.ca
      • Principal Investigator: Nathaniel Hawkins, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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"

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
mRNA COVID-19 vaccine associated myocarditis; Participants who had developed myocarditis within 42 days of getting a mRNA COVID-19 vaccine	Diagnostic test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire; Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire will be used to follow the clinical outcomes and patient reported outcomes to assess for study objectives
mRNA COVID-19 vaccine associated pericarditis; Participants who had developed pericarditis within 42 days of getting a mRNA COVID-19 vaccine	Diagnostic test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire; Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire will be used to follow the clinical outcomes and patient reported outcomes to assess for study objectives
COVID-19 infection associated myocarditis; Participants who had developed myocarditis within 42 days of being infected with the SARS-COV-2 virus	Diagnostic test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire; Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire will be used to follow the clinical outcomes and patient reported outcomes to assess for study objectives
COVID-19 infection associated pericarditis; Participants who had developed pericarditis within 42 days of being infected with the SARS-COV-2 virus	Diagnostic test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire; Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire will be used to follow the clinical outcomes and patient reported outcomes to assess for study objectives
Alternative etiology myocarditis; Any participants with myocarditis that is not associated with the mRNA COVID-19 vaccine or SARS-COV-2 viral infection	Other: Baseline Quality of Life questionnaire; Only baseline quality of life questionnaires will be utilized in the alternative etiology myocarditis cohort as they will not be followed up in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	From date of vaccination and up to 3 years
Recovery of cardiac function in patients with previously documented abnormal cardiac function	Patients with Left Ventricular Ejection Fraction (LVEF)<55% during anytime at baseline, with LVEF increase by 5% from worst baseline measurement	Through study completion, an average of 3 years
Quality of life using validated instruments at baseline, 3 months, 12 months, and annually	Quality of life: EQ-5D-5L questionnaire for adults or EQ-5D-Y questionnaire for children.	Through study completion, an average of 3 years
Depression and anxiety using validated instruments at baseline, 3 months, 12 months, and annually	Depression and anxiety data: PHQ-9 and GAD-7.	Through study completion, an average of 3 years
Physical activity using validated instruments at baseline, 3 months, 12 months, and annually	Physical activity: International Activity Questionnaire.	Through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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 atrial arrhythmias 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 recurrence of myocarditis/pericarditis 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

Collaborators and Investigators

• Sponsor: Cardiology Research UBC
• Investigators: Principal Investigator: Nathaniel Hawkins, MD, Vancouver General Hospital

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2023
• Primary Completion (Estimated): March 23, 2025
• Study Completion (Estimated): April 23, 2025

Study Registration Dates

• First Submitted: May 29, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Myocarditis; Pericarditis
• Other Study ID Numbers: MYCOVACC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No