CompletedNot Applicable

Myocardial Injury and Dysfunction Associated With COVID-19 Vaccination

United States10 participantsStarted 2021-05-12

Plain-language summary

The overall goal of the study is to investigate the characteristics and potential mechanisms responsible for myocardial injury and dysfunction in patients after COVID-19 vaccination. Cardiac damage will be assessed with cardiac MRI and endomyocardial biopsy (EmBx) histopathology. Myocardial gene expression will be measured in RNA extracted from EmBxs mRNA abundance compared to nonfailing and failing control hearts.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. age ≥18 years;
. clear evidence of myocardial involvement including:
. High Sensitivity Troponin I value of (≥0.05 ng/ml (the 99% upper bound)) OR
. an LVEF \< 50% OR
. ST-T change suggesting STEMI, NSTEMI or myopericarditis in the absence of coronary artery disease, OR
. new onset sustained VT or VF
. Late gadolinium enhancement or edema on cMRI consistent with myocardial injury or inflammation.
. Documentation of vaccination with mRNA-based COVID-19 vaccine.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Myocardial damage

Timeframe: clinical follow up for at least 30 days following endomyocardial biopsy

Histopathological changes assessed by light- and electron-microscopy in myocardial tissue

Timeframe: clinical follow up for at least 30 days following endomyocardial biopsy

Myocardial mRNA expression

Timeframe: clinical follow up for at least 30 days following endomyocardial biopsy

Trial details

NCT IDNCT05359250

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-30

View on ClinicalTrials.gov More Myocardial Injury trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. age ≥18 years;
. clear evidence of myocardial involvement including:
. High Sensitivity Troponin I value of (≥0.05 ng/ml (the 99% upper bound)) OR
. an LVEF \< 50% OR
. ST-T change suggesting STEMI, NSTEMI or myopericarditis in the absence of coronary artery disease, OR
. new onset sustained VT or VF
. Late gadolinium enhancement or edema on cMRI consistent with myocardial injury or inflammation.
. Documentation of vaccination with mRNA-based COVID-19 vaccine.

What they're measuring

Myocardial damage

Timeframe: clinical follow up for at least 30 days following endomyocardial biopsy

Histopathological changes assessed by light- and electron-microscopy in myocardial tissue

Timeframe: clinical follow up for at least 30 days following endomyocardial biopsy

Myocardial mRNA expression

Timeframe: clinical follow up for at least 30 days following endomyocardial biopsy

Myocardial Injury and Dysfunction Associated With COVID-19 Vaccination

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Myocardial Injury and Dysfunction Associated With COVID-19 Vaccination

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria