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Monitoring Heart Injury After COVID-19 Vaccination (MYOVAX Trial)
N/A
Waitlist Available
Led By Kate Hanneman, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Received at least one dose of a COVID-19 vaccine in the past 6 months (both Cohort A and B)
Must not have
Current history of COVID-19
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6months and 12months
Awards & highlights
No Placebo-Only Group
Summary
This trialwill study heart biomarkers to find out who's at risk for heart injury after the COVID-19 vaccine and how to reduce harm and follow-up.
Who is the study for?
This trial is for individuals aged 17 or older who developed signs of heart injury within a month after getting a COVID-19 vaccine, with no other known cause. Participants must have received at least one dose of the vaccine in the past six months and cannot currently have COVID-19 or conditions that make PET/MRI scans unsafe.
What is being tested?
The MYOVAX Study is testing how blood markers and advanced heart imaging (Cardiac PET/MRI) can help spot early signs of heart damage following COVID-19 vaccination. The goal is to identify those at risk, prevent complications, and decide if long-term monitoring is needed.
What are the potential side effects?
Since this study involves diagnostic procedures rather than medications, side effects are minimal but may include discomfort from blood draws or reactions to contrast agents used during cardiac imaging.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received at least one COVID-19 vaccine dose in the last 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I currently have COVID-19.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6months and 12months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6months and 12months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Prevalence of myocardial inflammation on PET/MRI
Secondary study objectives
Left ventricular dysfunction
Major adverse cardiac events (MACE)
Edema
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B - AsymptomaticExperimental Treatment2 Interventions
Those without signs or symptoms suggestive of myocarditis after COVID-19 vaccination
Group II: Cohort A - SymptomaticExperimental Treatment2 Interventions
Those with clinical findings suggestive of myocarditis/myocardial injury after COVID-19 vaccination
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood Biomarkers
2021
N/A
~30
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,526 Previous Clinical Trials
503,189 Total Patients Enrolled
Kate Hanneman, MDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
40 Total Patients Enrolled