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

N/AActive Not RecruitingNCT04967807

University Health Network, Toronto57 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

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

Interventions

Cardiac PET/MRIDIAGNOSTIC_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).

Blood BiomarkersDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Health Network

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Prevalence of myocardial inflammation on PET/MRI

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

Time frame: 6months and 12months

Secondary Outcomes

Major adverse cardiac events (MACE)

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

Time frame: 6months and 12months

Left ventricular dysfunction

Defined as Left Ventricular Ejection Fraction (LVEF) \< lower limit of normal on MRI

Time frame: 6months and 12months

Myocardial edema

Defined as high T2 \> upper limit of normal on MRI

Time frame: 6months and 12months

Data from ClinicalTrials.gov

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