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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Diagnostic Test: Cardiac PET/MRI
* Diagnostic Test: Blood Biomarkers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 17 years (both Cohort A and B) Received at least one dose of a COVID-19 vaccine in the past 6 months (both Cohort A and B) 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: Contraindications to cardiac PET/MRI Current history of COVID-19

Ages Eligible for Study
-----------------
Minimum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort A - Symptomatic<br>Those with clinical findings suggestive of myocarditis/myocardial injury after COVID-19 vaccination | Diagnostic Test: Cardiac PET/MRI<br>* 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).<br>Diagnostic Test: Blood Biomarkers<br>* Markers of cardiac damage, inflammation, circulating microRNA profiles, and COVID antibody levels will be evaluated in patients after COVID-19 vaccination.<br>|
| Other: Cohort B - Asymptomatic<br>Those without signs or symptoms suggestive of myocarditis after COVID-19 vaccination | Diagnostic Test: Cardiac PET/MRI<br>* 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).<br>Diagnostic Test: Blood Biomarkers<br>* Markers of cardiac damage, inflammation, circulating microRNA profiles, and COVID antibody levels will be evaluated in patients after COVID-19 vaccination.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Left ventricular dysfunction | Defined as Left Ventricular Ejection Fraction (LVEF) < lower limit of normal on MRI | 6months and 12months | 
| Myocardial edema | Defined as high T2 > upper limit of normal on MRI | 6months and 12months |