NCT04967807

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myocardial Injury
• Myocarditis
• COVID-19 Vaccination
• SARS-CoV-2
• Cardiac MRI

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cardiac PET/MRI	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).
DIAGNOSTIC_TEST	Blood Biomarkers	Markers of cardiac damage, inflammation, circulating microRNA profiles, and COVID antibody levels will be evaluated in patients after COVID-19 vaccination.

Timeline

• Start date: 2021-08-05
• Primary completion: 2026-08-05
• Completion: 2026-08-05
• First posted: 2021-07-20
• Last updated: 2026-03-27

Locations

1 site across 1 country: Canada