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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-05

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

None (Open Label)

Study Groups

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