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

University Health Network, Toronto

Status: Active, not recruiting

Conditions: Cardiac MRI; Myocarditis; COVID-19 Vaccination; SARS-CoV-2; Myocardial Injury

Treatments: Diagnostic Test: Blood Biomarkers; Diagnostic Test: Cardiac PET/MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT04967807

21-5621

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 17+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age ≥ 17 years (both Cohort A and B)
2. Received at least one dose of a COVID-19 vaccine in the past 6 months (both Cohort A and B)
3. 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

1. Contraindications to cardiac PET/MRI
2. Current history of COVID-19

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Cohort A - Symptomatic

Other group

Description:

Those with clinical findings suggestive of myocarditis/myocardial injury after COVID-19 vaccination

Treatment:

Diagnostic Test: Cardiac PET/MRI

Diagnostic Test: Blood Biomarkers

Cohort B - Asymptomatic

Other group

Description:

Those without signs or symptoms suggestive of myocarditis after COVID-19 vaccination

Treatment:

Diagnostic Test: Cardiac PET/MRI

Diagnostic Test: Blood Biomarkers