An observational study in Myocarditis, Myocarditis Acute and Pericarditis, sponsored by Cardiology Research UBC. Recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Cardiology Research UBC · Observational
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.
174 studies on the registry are indexed under Myocarditis; 75 are open to participants now.
This study's planned enrollment of 500 is above the median of 208 across 120 observational studies indexed under Myocarditis.
Browse Myocarditis studies →Cardiology Research UBC is the lead sponsor of 18 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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"
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion criteria for vaccine associated myocarditis/pericarditis.
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):
AND
Inclusion criteria for COVID-19 associated myocarditis/pericarditis
COVID-19 infection within the previous 42 days.
AND
Myocarditis/pericarditis as per Brighton Criteria for vaccine associated myocarditis/pericarditis.
AND
Inclusion criteria alternative etiology myocarditis.
Myocarditis/pericarditis as per Brighton Criteria for vaccine associated myocarditis/pericarditis.
AND
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 3 years
Individual components of primary composite endpoint at 30 days and 42 days post mRNA COVID-19 vaccination?
Time frame: From date of vaccination for up to three years
Rate of atrial arrhythmias after mRNA COVID-19 vaccination?
Time frame: From date of vaccination for up to three years
Rate of all-cause and cardiovascular mortality after mRNA COVID-19 vaccination?
Time frame: From date of vaccination for up to three years
Rate of all-cause and cardiovascular hospitalization after mRNA COVID-19 vaccination?
Time frame: From date of vaccination for up to three years
Rate of recurrence of myocarditis/pericarditis after mRNA COVID-19 vaccination?
Time frame: From date of vaccination for up to three years
Rate of constrictive pericarditis after mRNA COVID-19 vaccination?
Time frame: From date of vaccination for up to three years
Started Apr 2023 (actual). Primary completion is estimated for Mar 2027, 47 months after the start.
Of 70 non-industry observational studies under Myocarditis, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 251. This study's planned 47 months is below that.
Counting every sponsor, half of 71 studies reached it within 69 months; a quarter within 20 and three quarters within 251.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 3, 2026: primary completion Mar 2025 → Mar 2027 and completion Apr 2025 → Apr 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Cardiology Research UBC