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

University Health Network, Toronto2 sites in 1 country57 target enrollmentAugust 5, 2021

ConditionsMyocardial Injury Myocarditis COVID-19 Vaccination SARS-CoV-2 Cardiac MRI

InterventionsCardiac PET/MRI Blood Biomarkers

Overview

Phase: Not Applicable
Intervention: Cardiac PET/MRI
Conditions: Myocardial Injury
Sponsor: University Health Network, Toronto
Enrollment: 57
Locations: 2
Primary Endpoint: Prevalence of myocardial inflammation on PET/MRI
Status: Active, not recruiting
Last Updated: 8 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

August 5, 2021

End Date

August 5, 2026

Last Updated

8 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Health Network, Toronto

Responsible Party

Sponsor

Eligibility 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)