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Active (not recruiting) Not applicable NCT04967807

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

No applicable phase (e.g. observational)
Conditions: Myocardial Injury Myocarditis COVID-19 Vaccination SARS-CoV-2 Cardiac MRI

Sponsor: University Health Network, Toronto

trial.available_in: БГ
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.
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.
Who can participate
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
Interventions
Cardiac PET/MRI
DIAGNOSTIC_TEST
Blood Biomarkers
DIAGNOSTIC_TEST
Locations 1
Canada (1)
University Health Network
Toronto , Ontario
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
17 Years
Healthy volunteers
No
Start date
05.08.2021
Completion date
05.08.2026
Registry ID
NCT04967807
Source
clinicaltrials.gov
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