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

Study investigates heart injury after COVID-19 vaccines

NCT: NCT04967807 · Status: ACTIVE NOT RECRUITING · Phase: N/A · Sponsor: University Health Network, Toronto · Started: 2021-08-05 · Est. Completion: 2026-08-05

Plain English Summary

Myocardial Injury and Outcomes Following COVID-19 Vaccination (MYOVAX Study) is a Not Applicable clinical trial sponsored by University Health Network, Toronto studying Myocardial Injury, Myocarditis, COVID-19 Vaccination, SARS-CoV-2, Cardiac MRI. This study tests how to identify heart muscle injury after COVID-19 vaccination using blood tests and advanced imaging. It is for individuals aged 17 and older who have had a COVID-19 vaccine in the last 6 months and are experiencing symptoms potentially related to heart inflammation. Participation involves undergoing specialized heart imaging (PET/MRI) and providing blood samples. Currently, there are no specific alternative tests or treatments being compared within this observational study. The trial aims to enroll 57 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 17 or older and have received a COVID-19 vaccine in the past 6 months. You must have developed new symptoms suggesting heart inflammation (myocarditis) within a month of vaccination, with no other known cause. You cannot join if you have a condition that prevents you from having a cardiac PET/MRI scan or if you currently have COVID-19. This trial is studying Myocardial Injury, Myocarditis, COVID-19 Vaccination, SARS-CoV-2, Cardiac MRI, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how common heart inflammation is on specialized scans at 6 and 12 months, helping doctors understand the frequency of this potential side effect. The specific primary outcome measures are: Prevalence of myocardial inflammation on PET/MRI (6months and 12months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial aims to improve the early detection of heart muscle injury following COVID-19 vaccination, helping to manage potential risks and determine necessary follow-up care. This research targets Myocardial Injury, Myocarditis, COVID-19 Vaccination, SARS-CoV-2, Cardiac MRI, where improved treatment options are needed.

Investor Insight

This study addresses a critical safety concern following widespread vaccination, with potential implications for vaccine safety monitoring and cardiac care guidelines, indicating a need for robust pos

Is This Trial Right for Me?

Ask your doctor about the specific signs and symptoms of myocarditis and what the results of your cardiac imaging and blood tests mean. Participation involves undergoing a cardiac PET/MRI scan and providing blood samples, which are non-invasive procedures. The study will follow participants for up to 12 months to monitor for any heart-related events or changes. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

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

Trial Locations

Frequently Asked Questions

What is clinical trial NCT04967807?

NCT04967807 is a Not Applicable INTERVENTIONAL study titled "Myocardial Injury and Outcomes Following COVID-19 Vaccination (MYOVAX Study)." It is currently active, not recruiting and is sponsored by University Health Network, Toronto. The trial targets enrollment of 57 participants.

What conditions does NCT04967807 study?

This trial investigates treatments for Myocardial Injury, Myocarditis, COVID-19 Vaccination, SARS-CoV-2, Cardiac MRI. The primary condition under study is Myocardial Injury.

What treatments are being tested in NCT04967807?

The interventions being studied include: Cardiac PET/MRI (DIAGNOSTIC_TEST), Blood Biomarkers (DIAGNOSTIC_TEST). 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).

What does Not Applicable mean for NCT04967807?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT04967807?

This trial is currently "Active, Not Recruiting." It started on 2021-08-05. The estimated completion date is 2026-08-05.

Who is sponsoring NCT04967807?

NCT04967807 is sponsored by University Health Network, Toronto. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT04967807?

The trial aims to enroll 57 participants. The trial status is active, not recruiting.

How is NCT04967807 designed?

This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT04967807?

The primary outcome measures are: Prevalence of myocardial inflammation on PET/MRI (6months and 12months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT04967807 being conducted?

This trial is being conducted at 1 site, including Toronto, Ontario (Canada).

Where can I find official information about NCT04967807?

The official record for NCT04967807 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04967807. This government database provides the most up-to-date and detailed information about the trial.

What is NCT04967807 testing in simple terms?

This study tests how to identify heart muscle injury after COVID-19 vaccination using blood tests and advanced imaging. It is for individuals aged 17 and older who have had a COVID-19 vaccine in the last 6 months and are experiencing symptoms potentially related to heart inflammation.

Why is this trial significant?

This trial aims to improve the early detection of heart muscle injury following COVID-19 vaccination, helping to manage potential risks and determine necessary follow-up care.

What are the potential risks of participating in NCT04967807?

The main risks are associated with the cardiac PET/MRI scan, which involves radiation exposure and the use of contrast agents. Potential side effects from the scan can include allergic reactions to contrast dye or discomfort from the procedure. While the study is investigating potential heart injury, the risk of this occurring from the vaccine itself is generally considered very low. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT04967807?

Ask your doctor about the specific signs and symptoms of myocarditis and what the results of your cardiac imaging and blood tests mean. Participation involves undergoing a cardiac PET/MRI scan and providing blood samples, which are non-invasive procedures. The study will follow participants for up to 12 months to monitor for any heart-related events or changes. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT04967807 signal from an investment perspective?

This study addresses a critical safety concern following widespread vaccination, with potential implications for vaccine safety monitoring and cardiac care guidelines, indicating a need for robust pos This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves undergoing specialized heart imaging (PET/MRI) and providing blood samples. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

More Myocardial Injury Trials

View all Myocardial Injury clinical trials

This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.