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

Not Applicable

Active, not recruiting

• Conditions: COVID-19 Vaccination; SARS-CoV-2; Myocardial Injury; Myocarditis; Cardiac MRI
• Interventions: Diagnostic Test: Cardiac PET/MRI; Diagnostic Test: Blood Biomarkers

• Registration Number: NCT04967807
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-07-16
• Study First Posted: 2021-07-20
• Study Start: 2021-08-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A - Symptomatic	Cardiac PET/MRI	Those with clinical findings suggestive of myocarditis/myocardial injury after COVID-19 vaccination
Cohort A - Symptomatic	Blood Biomarkers	Those with clinical findings suggestive of myocarditis/myocardial injury after COVID-19 vaccination
Cohort B - Asymptomatic	Cardiac PET/MRI	Those without signs or symptoms suggestive of myocarditis after COVID-19 vaccination
Cohort B - Asymptomatic	Blood Biomarkers	Those without signs or symptoms suggestive of myocarditis after COVID-19 vaccination

Primary Outcome Measures

Name	Time	Method
Prevalence of myocardial inflammation on PET/MRI	6months and 12months	The prevalence of myocardial inflammation on PET/MRI will be compared between symptomatic and asymptomatic patients

Secondary Outcome Measures

Name	Time	Method
Myocardial edema	6months and 12months	Defined as high T2 \> upper limit of normal on MRI
Left ventricular dysfunction	6months and 12months	Defined as Left Ventricular Ejection Fraction (LVEF) \< lower limit of normal on MRI
Major adverse cardiac events (MACE)	6months and 12months	Defined as a composite of: 1. Arrhythmias - new atrial or ventricular arrhythmia; 2. Acute coronary syndrome; 1. Acute myocardial infarction; 2. Unstable angina requiring revascularization (PCI or CABG); 3. Heart failure hospitalization; 4. Cardiovascular death

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada