MYocarditis and/or Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study
MYCOVACC
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 23, 2023
CompletedFirst Submitted
Initial submission to the registry
May 29, 2023
CompletedFirst Posted
Study publicly available on registry
October 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2025
CompletedOctober 26, 2023
October 1, 2023
1.9 years
May 29, 2023
October 24, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (5)
mRNA COVID-19 vaccine associated myocarditis
Participants who had developed myocarditis within 42 days of getting a mRNA COVID-19 vaccine
mRNA COVID-19 vaccine associated pericarditis
Participants who had developed pericarditis within 42 days of getting a mRNA COVID-19 vaccine
COVID-19 infection associated myocarditis
Participants who had developed myocarditis within 42 days of being infected with the SARS-COV-2 virus
COVID-19 infection associated pericarditis
Participants who had developed pericarditis within 42 days of being infected with the SARS-COV-2 virus
Alternative etiology myocarditis
Any participants with myocarditis that is not associated with the mRNA COVID-19 vaccine or SARS-COV-2 viral infection
Interventions
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
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
Eligibility Criteria
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"
You may qualify if:
- COVID-19 vaccination within previous 42 days. AND
- 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
- At least one of the following objective findings (Brighton Criteria case definitions, Appendices 1 to 5):
- Histopathologic examination of myocardial tissue (autopsy or endomyocardial biopsy) showed myocardial inflammation.
- Elevated myocardial biomarker (Troponin T, Troponin I, or CK-MB).
- Cardiac MRI abnormality.
- Echocardiographic abnormality.
- New or worsening arrhythmia on electrocardiogram, Holter monitor, or telemetry.
- Elevated inflammation biomarkers: erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), hs-CRP, or D-Dimer.
- Physical examination pericardial friction rub or pulsus paradoxus.
- Pericardial fluid or inflammation by imaging (echo, MRI, or CT).
- Enlarged heart on chest radiograph.
- +10 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathaniel Hawkins, MD
Vancouver General Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2023
First Posted
October 26, 2023
Study Start
April 23, 2023
Primary Completion
March 23, 2025
Study Completion
April 23, 2025
Last Updated
October 26, 2023
Record last verified: 2023-10