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NCT Number: NCT04967807

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Myocardial Injury COVID-19 Vaccination Cardiac MRI Cardiomyopathies Cardiovascular Diseases Heart Diseases Myocarditis SARS-CoV-2

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Exclusion criteria

  • Contraindications to cardiac PET/MRI
  • Current history of COVID-19

Treatment and study plan

Cardiac PET/MRI

Diagnostic Test

An imaging technique that combines the strengths of both MRI and PET into one comprehensive study. This technique allows for detailed myocardial tissue characterization with MRI (including assessment of myocardial edema and fibrosis) and metabolic changes (including myocardial inflammation).

Blood Biomarkers

Diagnostic Test

Markers of cardiac damage, inflammation, circulating microRNA profiles, and COVID antibody levels will be evaluated in patients after COVID-19 vaccination.

Primary outcomes

  1. Prevalence of myocardial inflammation on PET/MRI

    Time frame: 6months and 12months

    The prevalence of myocardial inflammation on PET/MRI will be compared between symptomatic and asymptomatic patients

Secondary outcomes

  1. Major adverse cardiac events (MACE)

    Time frame: 6months and 12months

    Defined as a composite of:

    • Arrhythmias - new atrial or ventricular arrhythmia
    • Acute coronary syndrome
    • Acute myocardial infarction
    • Unstable angina requiring revascularization (PCI or CABG)
    • Heart failure hospitalization
    • Cardiovascular death

  2. Left ventricular dysfunction

    Time frame: 6months and 12months

    Defined as Left Ventricular Ejection Fraction (LVEF) < lower limit of normal on MRI

  3. Myocardial edema

    Time frame: 6months and 12months

    Defined as high T2 > upper limit of normal on MRI

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: MYOVAX

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2021
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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