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Cohort A - Symptomatic for Myocarditis (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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6months and 12months
Awards & highlights
MYOVAX Trial 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.Check my eligibility
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.See study design
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.
MYOVAX Trial 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.
MYOVAX Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prevalence of myocardial inflammation on PET/MRI
Secondary outcome measures
Left ventricular dysfunction
Major adverse cardiac events (MACE)
Edema
MYOVAX 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
1,478 Previous Clinical Trials
485,343 Total Patients Enrolled
Kate Hanneman, MDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
60 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applicants still being accepted for participation in this trial?
"As per clinicaltrials.gov, this medical experiment is presently enrolling participants. It was initially made available on August 5th 2021 and its details were modified most recently on November 1st 2022."
Answered by AI
What is the uppermost limit of subjects engaging in this clinical trial?
"Affirmative. Information posted on clinicaltrials.gov demonstrates that this research initiative, which was initially made public on August 5th 2021, is still recruiting participants. In total 80 patients must be accepted from a single site."
Answered by AI
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