Clinical trial NCT04967807: Myocardial Injury and Outcomes Following COVID-19 Vaccination (MYOVAX Study)
Official title: Myocardial Injury and Outcomes Following COVID-19 Vaccination (MYOVAX Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myocardial Injury
Myocarditis
COVID-19 Vaccination
SARS-CoV-2
Cardiac MRI
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 57
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of myocardial inflammation on PET/MRI
timeFrame: 6months and 12months
Secondary outcomes:
measure: Major adverse cardiac events (MACE)
timeFrame: 6months and 12months
measure: Left ventricular dysfunction
timeFrame: 6months and 12months
measure: Myocardial edema
timeFrame: 6months and 12months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Kate Hanneman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.