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 range18 Years

SexALL

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.

Exclusion criteria

✕. Hemodynamic instability as evidenced by escalating doses of inotropic agents or vasopressors within the prior 24 hours
✕. Respiratory instability as evidenced by increasing oxygen requirements over the 24 hours prior to consent or FiO2 requirement ≥ 60 %.
✕. evidence that respiratory failure is the primary reason for myocardial dysfunction;
✕. Moderate to severe pulmonary hypertension (mean PAP ≥35 mmHg);
✕. INR \>1.8 on no anticoagulation or contraindication to withdrawing anticoagulation;

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 range18 Years

SexALL

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.

Exclusion criteria

✕. Hemodynamic instability as evidenced by escalating doses of inotropic agents or vasopressors within the prior 24 hours
✕. Respiratory instability as evidenced by increasing oxygen requirements over the 24 hours prior to consent or FiO2 requirement ≥ 60 %.
✕. evidence that respiratory failure is the primary reason for myocardial dysfunction;
✕. Moderate to severe pulmonary hypertension (mean PAP ≥35 mmHg);
✕. INR \>1.8 on no anticoagulation or contraindication to withdrawing anticoagulation;

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