Monitoring Heart Injury After COVID-19 Vaccination

(MYOVAX Trial)

Overseen By Paaladinesh Thavendiranathan, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Contraindications cardiac PET/MRI, COVID-19

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

57 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Blood Biomarkers, Cardiac PET/MRI for monitoring heart injury after COVID-19 vaccination?

Research shows that cardiac MRI can identify patterns of heart injury, such as myocarditis, after COVID-19 vaccination, with findings indicating less severe abnormalities compared to other causes of myocarditis and no adverse events in the short term. ^{1 2 3 4 5}

Is it safe to monitor heart injury after COVID-19 vaccination using Blood Biomarkers and Cardiac PET/MRI?

Research shows that while some people may experience mild heart inflammation after COVID-19 vaccination, these cases are generally less severe than other types of heart inflammation and do not lead to serious problems in the short term. Monitoring methods like Blood Biomarkers and Cardiac PET/MRI have been used safely to study these effects. ^{1 3 5 6 7}

How does this treatment for monitoring heart injury after COVID-19 vaccination differ from other treatments?

This treatment is unique because it uses cardiovascular magnetic resonance (CMR) imaging to monitor heart injury after COVID-19 vaccination, focusing on detecting subclinical myocarditis (heart muscle inflammation) and myocardial tissue changes, which are not typically assessed in standard treatments. ^{2 3 4 6 8}

Research Team

Kate Hanneman, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for individuals aged 17 or older who developed signs of heart injury within a month after getting a COVID-19 vaccine, with no other known cause. Participants must have received at least one dose of the vaccine in the past six months and cannot currently have COVID-19 or conditions that make PET/MRI scans unsafe.

Inclusion Criteria

I am 17 years old or older.

I have received at least one COVID-19 vaccine dose in the last 6 months.

I've had heart symptoms after a COVID vaccine, with no other cause.

Exclusion Criteria

Contraindications to cardiac PET/MRI

I currently have COVID-19.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Participants undergo cardiac blood and imaging biomarker assessments to identify risk of myocardial injury after COVID-19 vaccination

4 weeks

Follow-up

Participants are monitored for myocardial inflammation and major adverse cardiac events using PET/MRI and other assessments

12 months

Treatment Details

Interventions

• Blood Biomarkers
• Cardiac PET/MRI

Trial Overview The MYOVAX Study is testing how blood markers and advanced heart imaging (Cardiac PET/MRI) can help spot early signs of heart damage following COVID-19 vaccination. The goal is to identify those at risk, prevent complications, and decide if long-term monitoring is needed.

Participant Groups

Group I: Cohort B - Asymptomatic Experimental Treatment 2 Interventions

Those without signs or symptoms suggestive of myocarditis after COVID-19 vaccination

Group II: Cohort A - Symptomatic Experimental Treatment 2 Interventions

Those with clinical findings suggestive of myocarditis/myocardial injury after COVID-19 vaccination

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Myocardial Injury Pattern at MRI in COVID-19 Vaccine-Associated Myocarditis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Patterns of myocardial injury in recovered troponin-positive COVID-19 patients assessed by cardiovascular magnetic resonance. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Myocardial Inflammation on FDG PET/MRI and Clinical Outcomes in Symptomatic and Asymptomatic Participants after COVID-19 Vaccination. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Left ventricular global longitudinal strain in identifying subclinical myocardial dysfunction among patients hospitalized with COVID-19. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Admission and follow-up cardiac magnetic resonance imaging findings in BNT162b2 Vaccine-Related myocarditis in adolescents. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Post-COVID-19 vaccination myocarditis: a prospective cohort study pre and post vaccination using cardiovascular magnetic resonance. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Case Series of Potential Cardiac Inflammation Associated With Various SARS-CoV-2 Vaccinations Assessed by Cardiac MRI. [2022]

8. England pubmed.ncbi.nlm.nih.gov

T2-mapping increase is the prevalent imaging biomarker of myocardial involvement in active COVID-19: a Cardiovascular Magnetic Resonance study. [2021]