Myocardial Injury and Outcomes Following COVID-19 Vaccination (MYOVAX Study)
Study Details
Study Description
Brief 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 myocardial injury after vaccination.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Cohort A - Symptomatic Those with clinical findings suggestive of myocarditis/myocardial injury after COVID-19 vaccination |
Diagnostic Test: Cardiac PET/MRI
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).
Diagnostic Test: Blood Biomarkers
Markers of cardiac damage, inflammation, circulating microRNA profiles, and COVID antibody levels will be evaluated in patients after COVID-19 vaccination.
|
| Other: Cohort B - Asymptomatic Those without signs or symptoms suggestive of myocarditis after COVID-19 vaccination |
Diagnostic Test: Cardiac PET/MRI
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).
Diagnostic Test: Blood Biomarkers
Markers of cardiac damage, inflammation, circulating microRNA profiles, and COVID antibody levels will be evaluated in patients after COVID-19 vaccination.
|
Outcome Measures
Primary Outcome Measures
- Prevalence of myocardial inflammation on PET/MRI [6months and 12months]
The prevalence of myocardial inflammation on PET/MRI will be compared between symptomatic and asymptomatic patients
Secondary Outcome Measures
- Major adverse cardiac events (MACE) [6months and 12months]
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
- Left ventricular dysfunction [6months and 12months]
Defined as Left Ventricular Ejection Fraction (LVEF) < lower limit of normal on MRI
- Myocardial edema [6months and 12months]
Defined as high T2 > upper limit of normal on MRI
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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)
Exclusion Criteria:
-
Contraindications to cardiac PET/MRI
-
Current history of COVID-19
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Health Network | Toronto | Ontario | Canada | M5G 2C4 |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
- Principal Investigator: Kate Hanneman, MD, University Health Network, Toronto
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-5621