MyocarditisMYCOVACCNCT06103123
MYocarditis and/or Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study
An observational study of Myocarditis and Myocarditis Acute, run by Cardiology Research UBC at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocarditis, Myocarditis Acute, Pericarditis
- What is being tested?
- Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire and Baseline Quality of Life questionnaire
- Type of treatment
- Vaccines
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 23 Apr 2023to 23 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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"
Who may be able to join
- Inclusion criteria for vaccine associated myocarditis/pericarditis.
- 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
Show all 27Show fewer
- 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.
- AND
- No alternative cause of presentation. e.g. infectious or autoimmune myocarditis.
- 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
- No alternative cause of presentation.
- Myocarditis/pericarditis as per Brighton Criteria for vaccine associated myocarditis/pericarditis.
- AND
- No alternative cause of presentation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Jenny Petterson, MSc, 604 - 875 - 5104, jenny.petterson@vch.ca
Nathaniel Hawkins, MD
About this study
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.
- Conditions
- Myocarditis, Myocarditis Acute, Pericarditis, Pericarditis Acute
- Being tested
- Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire, Baseline Quality of Life questionnaire
- Medical subject headings
- Myocarditis, Pericarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaireDiagnostic test
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
Baseline Quality of Life questionnaireOther
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
| Study group | Role | What they receive |
|---|---|---|
| mRNA COVID-19 vaccine associated myocarditis | Participants who had developed myocarditis within 42 days of getting a mRNA COVID-19 vaccine Receives: Diagnostic Test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire | |
| mRNA COVID-19 vaccine associated pericarditis | Participants who had developed pericarditis within 42 days of getting a mRNA COVID-19 vaccine Receives: Diagnostic Test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire | |
| COVID-19 infection associated myocarditis | Participants who had developed myocarditis within 42 days of being infected with the SARS-COV-2 virus Receives: Diagnostic Test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire | |
| COVID-19 infection associated pericarditis | Participants who had developed pericarditis within 42 days of being infected with the SARS-COV-2 virus Receives: Diagnostic Test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire | |
| Alternative etiology myocarditis | Any participants with myocarditis that is not associated with the mRNA COVID-19 vaccine or SARS-COV-2 viral infection Receives: Other: Baseline Quality of Life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?
Measured: From date of vaccination for up to three years
Rate of atrial arrhythmias after mRNA COVID-19 vaccination?
Measured: From date of vaccination for up to three years
Rate of all-cause and cardiovascular mortality after mRNA COVID-19 vaccination?
Measured: From date of vaccination for up to three years
Rate of all-cause and cardiovascular hospitalization after mRNA COVID-19 vaccination?
Measured: From date of vaccination for up to three years
Rate of recurrence of myocarditis/pericarditis after mRNA COVID-19 vaccination?
Measured: From date of vaccination for up to three years
Rate of constrictive pericarditis after mRNA COVID-19 vaccination?
Measured: From date of vaccination for up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start23 Apr 2023
- Primary completion23 Mar 2027 (estimated)
- Study completion23 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiology Research UBC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathaniel Hawkins, MD, Principal investigator, Vancouver General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103123
- Sponsor's protocol ID
- MYCOVACC
- Acronym
- MYCOVACC
- Status last verified
- Nov 2026
- First submitted
- 29 May 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MYocarditis and/or Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study
- ClinicalTrials.gov ID
- NCT06103123
- Acronym / sponsor ID
- MYCOVACC / MYCOVACC
- Conditions
- Myocarditis, Myocarditis Acute, Pericarditis, Pericarditis Acute
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cardiology Research UBCUniversity, hospital or other
- Study start
- 23 Apr 2023 (actual)
- Primary completion
- 23 Mar 2027 (estimated)
- Study completion
- 23 Apr 2027 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| mRNA COVID-19 vaccine associated myocarditis | – | Diagnostic Test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaireParticipants who had developed myocarditis within 42 days of getting a mRNA COVID-19 vaccine |
| mRNA COVID-19 vaccine associated pericarditis | – | Diagnostic Test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaireParticipants who had developed pericarditis within 42 days of getting a mRNA COVID-19 vaccine |
| COVID-19 infection associated myocarditis | – | Diagnostic Test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaireParticipants who had developed myocarditis within 42 days of being infected with the SARS-COV-2 virus |
| COVID-19 infection associated pericarditis | – | Diagnostic Test: Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaireParticipants who had developed pericarditis within 42 days of being infected with the SARS-COV-2 virus |
| Alternative etiology myocarditis | – | Other: Baseline Quality of Life questionnaireAny participants with myocarditis that is not associated with the mRNA COVID-19 vaccine or SARS-COV-2 viral infection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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"
Key inclusion criteria (27 listed)
- Inclusion criteria for vaccine associated myocarditis/pericarditis.
- 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
- AND
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaireStand 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 | Diagnostic test | COVID-19 infection associated myocarditis, COVID-19 infection associated pericarditis, mRNA COVID-19 vaccine associated myocarditis, mRNA COVID-19 vaccine associated pericarditis |
| Baseline Quality of Life questionnaireOnly baseline quality of life questionnaires will be utilized in the alternative etiology myocarditis cohort as they will not be followed up in the study | Other | Alternative etiology myocarditis |
Primary outcome
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)
Time frame: 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.
Recovery of cardiac function in patients with previously documented abnormal cardiac function
Time frame: 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
Quality of life using validated instruments at baseline, 3 months, 12 months, and annually
Time frame: Through study completion, an average of 3 years
Quality of life: EQ-5D-5L questionnaire for adults or EQ-5D-Y questionnaire for children.
Depression and anxiety using validated instruments at baseline, 3 months, 12 months, and annually
Time frame: Through study completion, an average of 3 years
Depression and anxiety data: PHQ-9 and GAD-7.
Physical activity using validated instruments at baseline, 3 months, 12 months, and annually
Time frame: Through study completion, an average of 3 years
Physical activity: International Activity Questionnaire.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Related InfoLink provided by the sponsor.
Related trials for Myocarditis
Recruiting
Baduanjin Rehabilitation for Functional Restoration in ICI-Associated Myocarditis
Immune Checkpoint Inhibitors Related Myocarditis
Not yet recruitingObservational study
Monitoring and Rehabilitation for ICIACI Rehabilitation：A Cohort Study
Immune Checkpoint Inhibitor-Related Myocarditis
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathaniel Hawkins, MD principal investigator
Vancouver General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis and Myocarditis Acute, run by Cardiology Research UBC at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Petterson, MSc (604-875-5104, jenny.petterson@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: From date of vaccination and up to 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.