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

SARS-CoV-2 Clinical Trial

— MYOVAX  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04967807
• Other study ID #: 21-5621
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 5, 2021
• Est. completion date: August 5, 2024

Study information

• Verified date: December 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: August 5, 2024
• Est. primary completion date: August 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac MRI
• COVID-19
• Myocardial Injury
• Myocarditis
• SARS-CoV-2
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Major adverse cardiac events (MACE)	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	6months and 12months
Secondary	Left ventricular dysfunction	Defined as Left Ventricular Ejection Fraction (LVEF) < lower limit of normal on MRI	6months and 12months
Secondary	Myocardial edema	Defined as high T2 > upper limit of normal on MRI	6months and 12months