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

NCT04967807 | Active Not Recruiting

• 1 other identifier: 21-5621
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of myocardial inflammation on PET/MRI

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

  6months and 12months

Secondary Outcomes (3)

• Major adverse cardiac events (MACE)

  6months and 12months

• Left ventricular dysfunction

  6months and 12months

• Myocardial edema

  6months and 12months

Study Arms (2)

Cohort A - Symptomatic

OTHER

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

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

Cohort B - Asymptomatic

OTHER

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

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

Interventions

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).

Cohort A - Symptomatic; Cohort B - Asymptomatic

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.

Cohort A - Symptomatic; Cohort B - Asymptomatic

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

• Marschner CA, Thavendiranathan P, Gustafson D, Howe KL, Fish JE, Iwanochko RM, Wald RM, Abdel-Qadir H, Epelman S, Cheung AM, Hong R, Hanneman K. Myocardial Inflammation on FDG PET/MRI and Clinical Outcomes in Symptomatic and Asymptomatic Participants after COVID-19 Vaccination. Radiol Cardiothorac Imaging. 2023 Mar 9;5(2):e220247. doi: 10.1148/ryct.220247. eCollection 2023 Apr.

  PMID: 36987440 BACKGROUND

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Study Officials

• Kate Hanneman, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study population will include 2 cohorts of patients post COVID-19 vaccination. Cohort A) symptomatic patients with clinical signs or symptoms suggestive of myocardial injury and Cohort B) asymptomatic patients without symptoms suggestive of myocardial injury who have had prior cardiac MRI.

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 20, 2021
• Study Start: August 5, 2021
• Primary Completion (Estimated): August 5, 2026
• Study Completion (Estimated): August 5, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)