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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6months and 12months for reporting.

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,468 Previous Clinical Trials

484,433 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

Recent research and studies

clinicaltrials.govStudy

Myocardial Injury and Outcomes Following COVID-19 Vaccination (MYOVAX Study)

2021. "Myocardial Injury and Outcomes Following COVID-19 Vaccination (MYOVAX Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04967807.

All > Myocarditis