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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify early signs of heart issues following a COVID-19 vaccination. Researchers will use blood tests (blood biomarkers) and heart scans (cardiac PET/MRI) to detect heart damage. Participants will be divided into two groups: one with individuals showing heart-related symptoms post-vaccination and another without symptoms. The trial is ideal for those who received a COVID-19 vaccine in the last six months and have experienced new heart-related symptoms without any other known cause. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance early detection of heart issues 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 prior data suggests that these cardiac monitoring methods are safe?

Research shows that heart inflammation, known as myocarditis, can occur after receiving a COVID-19 vaccine. The risk is highest for young males within 14 days of an mRNA vaccine. However, one study found that while the chance of developing myocarditis after vaccination is 3.2 times higher than normal, it rises to 18.3 times after contracting COVID-19 itself. This indicates that although there is a risk with the vaccine, it is lower than the risk from the virus.

For heart imaging, research indicates that heart injury without symptoms is uncommon after vaccination. Tests like cardiac PET/MRI scans usually appear normal in these cases. When heart injury does occur, it is generally less severe than from other causes of myocarditis.

These findings suggest that while some risks exist, they are generally low and less severe compared to other conditions. This information can help those considering participation in a clinical trial understand the safety context. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses advanced imaging techniques like Cardiac PET/MRI to closely monitor heart health after COVID-19 vaccinations. Unlike traditional methods that rely on symptoms to detect heart issues, this approach can identify myocardial injury early, even in those without symptoms. Additionally, analyzing blood biomarkers can provide specific insights into heart function, potentially offering a faster and more detailed understanding of the heart's condition post-vaccination. This could lead to earlier interventions and more personalized care for those at risk.

What evidence suggests that this trial's methods could be effective for monitoring heart injury after COVID-19 vaccination?

This trial will monitor heart injury after COVID-19 vaccination in two separate cohorts. Research has shown that the chance of developing heart inflammation, known as myocarditis, is lower after receiving a COVID-19 vaccine than after contracting COVID-19. One study found that the risk of myocarditis after vaccination was 3.2 times higher than normal, while it was 18.3 times higher after infection. Heart scans have indicated that serious heart muscle damage is uncommon after vaccination. Another study found that any heart issues observed on scans post-vaccination were generally milder than other types of myocarditis. Overall, these findings suggest that while there is some risk, myocarditis from vaccines is rare and usually not severe. ^{1 2 3 4 6}

Who Is on the Research Team?

Kate Hanneman, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9538893/

Myocarditis following COVID‐19 vaccine - PubMed Central - NIH Each cohort consisted of more than 800 000 individuals. Relative risk for developing myocarditis after vaccine was 3.2, while it is 18.3 after getting COVID‐19 ...

2. pfizer.com pfizer.com/news/announcements/pfizer-shares-available-analyses-myocarditis-and-covid-19-vaccines

Pfizer Shares Available Analyses of Myocarditis and ... Several important studies have reported on the potential outcomes of myocarditis following COVID-19 infection and vaccination. A systematic ...

3. nature.com nature.com/articles/s41541-024-00893-1

Myocarditis associated with COVID-19 vaccination In line with these results, a more recent study showed that the relative risk of heart failure within 90 days was 0.56 and 1.48 for myocarditis ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.122.321881

Vaccination-Associated Myocarditis and Myocardial Injury Myocarditis associated with SARS-COVID-19 vaccines occurs primarily with mRNA platform vaccines, which are also the most effective.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352906723001112

COVID-19 vaccine-associated myocarditis: Analysis of the ... EudraVigilance database analysis revealed 16,514 reported cases of myocarditis or pericarditis due to the vaccination with COVID-19 vaccines.

6. fda.gov fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-approves-required-updated-warning-labeling-mrna-covid-19-vaccines-regarding-myocarditis-and

FDA Approves Required Updated Warning in Labeling of ... The observed risk of myocarditis and pericarditis following vaccination with mRNA COVID-19 vaccines has been highest in males 12 through 24 years of age.