Myocardial InjuryMYOVAXNCT04967807
Myocardial Injury and Outcomes Following COVID-19 Vaccination (MYOVAX Study)
A study testing Cardiac PET/MRI and Blood Biomarkers in people with Myocardial Injury and Myocarditis, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The study will focus on cardiac blood and imaging biomarkers to facilitate early recognition of patients at risk for myocardial injury after COVID-19 vaccination. Ultimately, the intention is to identify patients at risk, reduce adverse events, and determine the need for longer-term follow-up in patients with… Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Injury, Myocarditis, COVID-19 Vaccination
- What is being tested?
- Cardiac PET/MRI and Blood Biomarkers
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- 5 Aug 2021to 5 Aug 2026
- Phase
- Interventional
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 17 years (both Cohort A and B)
- Received at least one dose of a COVID-19 vaccine in the past 6 months (both Cohort A and B)
- Developed new clinical signs or symptoms suggestive of myocarditis/myocardial injury within one month of COVID vaccine administration without other known cause (Cohort A, only)
Who cannot join
- Contraindications to cardiac PET/MRI
- Current history of COVID-19
Trial locations and contacts
1 site in 1 country.
About this study
The study will focus on cardiac blood and imaging biomarkers to facilitate early recognition of patients at risk for myocardial injury after COVID-19 vaccination. Ultimately, the intention is to identify patients at risk, reduce adverse events, and determine the need for longer-term follow-up in patients with myocardial injury after vaccination.
Read the detailed description
Coronavirus disease 2019 (COVID-19) vaccination frequently leads to minor side effects that may be more intense after the second dose, including fatigue and pain. However, there are emerging reports of more serious side effects in a minority of patients including myocarditis. Given the recent introduction of COVID-19 vaccination, there is limited understanding of: (i) prevalence and pattern of myocardial injury post vaccination, (ii) the risk factors for myocardial injury and adverse cardiac events post vaccination, and (iii) imaging and blood biomarkers for early recognition of patients at risk of adverse outcomes.
This study will address the above-mentioned knowledge gaps by focusing on patients who have received at least one dose of a COVID-19 vaccine. The study will focus on cardiac blood and imaging biomarkers to facilitate early recognition of patients at risk for myocardial injury after COVID-19 vaccination. Ultimately, the intention is to identify patients at risk, reduce adverse events, and determine the need for longer-term follow-up in patients with myocardial injury after vaccination.
- Conditions
- Myocardial Injury, Myocarditis, COVID-19 Vaccination, SARS-CoV-2, Cardiac MRI
- Being tested
- Cardiac PET/MRI, Blood Biomarkers
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac PET/MRIDiagnostic test
An imaging technique that combines the strengths of both MRI and PET into one comprehensive study. This technique allows for detailed myocardial tissue characterization with MRI (including assessment of myocardial edema and fibrosis) and metabolic changes (including myocardial inflammation).
Blood BiomarkersDiagnostic test
Markers of cardiac damage, inflammation, circulating microRNA profiles, and COVID antibody levels will be evaluated in patients after COVID-19 vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - Symptomatic | Other | Those with clinical findings suggestive of myocarditis/myocardial injury after COVID-19 vaccination Receives: Diagnostic Test: Cardiac PET/MRI; Diagnostic Test: Blood Biomarkers |
| Cohort B - Asymptomatic | Other | Those without signs or symptoms suggestive of myocarditis after COVID-19 vaccination Receives: Diagnostic Test: Cardiac PET/MRI; Diagnostic Test: Blood Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of myocardial inflammation on PET/MRI
The prevalence of myocardial inflammation on PET/MRI will be compared between symptomatic and asymptomatic patients
Measured: 6months and 12months
Secondary outcomes (3)
Major adverse cardiac events (MACE)
Defined as a composite of:
- Arrhythmias - new atrial or ventricular arrhythmia
- Acute coronary syndrome
- Acute myocardial infarction
- Unstable angina requiring revascularization (PCI or CABG)
- Heart failure hospitalization
- Cardiovascular death
Measured: 6months and 12months
Left ventricular dysfunction
Defined as Left Ventricular Ejection Fraction (LVEF) < lower limit of normal on MRI
Measured: 6months and 12months
Myocardial edema
Defined as high T2 > upper limit of normal on MRI
Measured: 6months and 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start5 Aug 2021
- Primary completion5 Aug 2026 (estimated)
- Study completion5 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InjuryStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study population will include 2 cohorts of patients post COVID-19 vaccination. Cohort A) symptomatic patients with clinical signs or symptoms suggestive of myocardial injury and Cohort B) asymptomatic patients without symptoms suggestive of myocardial injury who have had prior cardiac MRI.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate Hanneman, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967807
- Sponsor's protocol ID
- 21-5621
- Acronym
- MYOVAX
- Status last verified
- Apr 2026
- First submitted
- 29 Jun 2021
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marschner CA, Thavendiranathan P, Gustafson D, Howe KL, Fish JE, Iwanochko RM, Wald RM, Abdel-Qadir H, Epelman S, Cheung AM, Hong R, Hanneman K. Myocardial Inflammation on FDG PET/MRI and Clinical Outcomes in Symptomatic and Asymptomatic Participants after COVID-19 Vaccination. Radiol Cardiothorac Imaging. 2023 Mar 9;5(2):e220247. doi: 10.1148/ryct.220247. eCollection 2023 Apr.
PubMed 36987440
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Injury and Outcomes Following COVID-19 Vaccination (MYOVAX Study)
- ClinicalTrials.gov ID
- NCT04967807
- Acronym / sponsor ID
- MYOVAX / 21-5621
- Conditions
- Myocardial Injury, Myocarditis, COVID-19 Vaccination, SARS-CoV-2, Cardiac MRI
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 5 Aug 2026 (estimated)
- Study completion
- 5 Aug 2026 (estimated)
- First posted
- 20 Jul 2021 (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.
The study will focus on cardiac blood and imaging biomarkers to facilitate early recognition of patients at risk for myocardial injury after COVID-19 vaccination. Ultimately, the intention is to identify patients at risk, reduce adverse events, and determine the need for longer-term follow-up in patients with myocardial injury after vaccination.
Detailed description
Coronavirus disease 2019 (COVID-19) vaccination frequently leads to minor side effects that may be more intense after the second dose, including fatigue and pain. However, there are emerging reports of more serious side effects in a minority of patients including myocarditis. Given the recent introduction of COVID-19 vaccination, there is limited understanding of: (i) prevalence and pattern of myocardial injury post vaccination, (ii) the risk factors for myocardial injury and adverse cardiac events post vaccination, and (iii) imaging and blood biomarkers for early recognition of patients at risk of adverse outcomes.
This study will address the above-mentioned knowledge gaps by focusing on patients who have received at least one dose of a COVID-19 vaccine. The study will focus on cardiac blood and imaging biomarkers to facilitate early recognition of patients at risk for myocardial injury after COVID-19 vaccination. Ultimately, the intention is to identify patients at risk, reduce adverse events, and determine the need for longer-term follow-up in patients with myocardial injury after vaccination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study population will include 2 cohorts of patients post COVID-19 vaccination. Cohort A) symptomatic patients with clinical signs or symptoms suggestive of myocardial injury and Cohort B) asymptomatic patients without symptoms suggestive of myocardial injury who have had prior cardiac MRI.
| Arm | Type | Receives |
|---|---|---|
| Cohort A - Symptomatic | Other | Diagnostic Test: Cardiac PET/MRI, Diagnostic Test: Blood BiomarkersThose with clinical findings suggestive of myocarditis/myocardial injury after COVID-19 vaccination |
| Cohort B - Asymptomatic | Other | Diagnostic Test: Cardiac PET/MRI, Diagnostic Test: Blood BiomarkersThose without signs or symptoms suggestive of myocarditis after COVID-19 vaccination |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 17 years (both Cohort A and B)
- Received at least one dose of a COVID-19 vaccine in the past 6 months (both Cohort A and B)
- Developed new clinical signs or symptoms suggestive of myocarditis/myocardial injury within one month of COVID vaccine administration without other known cause (Cohort A, only)
Key exclusion criteria (2 listed)
- Contraindications to cardiac PET/MRI
- Current history of COVID-19
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 |
|---|---|---|
| Cardiac PET/MRIAn imaging technique that combines the strengths of both MRI and PET into one comprehensive study. This technique allows for detailed myocardial tissue characterization with MRI (including assessment of myocardial edema and fibrosis) and metabolic changes (including myocardial inflammation). | Diagnostic test | Cohort A - Symptomatic, Cohort B - Asymptomatic |
| Blood BiomarkersMarkers of cardiac damage, inflammation, circulating microRNA profiles, and COVID antibody levels will be evaluated in patients after COVID-19 vaccination. | Diagnostic test | Cohort A - Symptomatic, Cohort B - Asymptomatic |
Primary outcome
Prevalence of myocardial inflammation on PET/MRI
Time frame: 6months and 12months
The prevalence of myocardial inflammation on PET/MRI will be compared between symptomatic and asymptomatic patients
3 secondary outcomes
Major adverse cardiac events (MACE)
Time frame: 6months and 12months
Left ventricular dysfunction
Time frame: 6months and 12months
Myocardial edema
Time frame: 6months and 12months
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 24 Apr 2026.
- Background: PubMed 36987440Marschner CA, Thavendiranathan P, Gustafson D, Howe KL, Fish JE, Iwanochko RM, Wald RM, Abdel-Qadir H, Epelman S, Cheung AM, Hong R, Hanneman K. Myocardial Inflammation on FDG PET/MRI and Clinical Outcomes in Symptomatic and Asymptomatic Participants after COVID-19 Vaccination. Radiol Cardiothorac Imaging. 2023 Mar 9;5(2):e220247. doi: 10.1148/ryct.220247. eCollection 2023 Apr.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kate Hanneman, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac PET/MRI and Blood Biomarkers in people with Myocardial Injury and Myocarditis, run by University Health Network, Toronto 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 3 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of myocardial inflammation on PET/MRI (time frame: 6months and 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04967807, which also lists 1 linked publication.
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 24 Apr 2026.