Myocardial Injury and Dysfunction Associated With COVID-19 Vaccination
Key facts
- Who runs it
- University of Colorado, Denver
- Where
- Aurora, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 10 people enrolled
- Started
- 12 May 2021
- Ended
- 30 Dec 2024
- Type of study
- Observational
- Record updated
- 4 April 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
- No history of COVID-19, or a negative SARS-CoV-2 PCR or other FDA approved laboratory test within 1 week of enrollment
- Patient and/or legally authorized representative must be competent to understand and agree with informed consent form
Who cannot take part
- 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)
- Acute or chronic kidney disease with glomerular filtration rate < 30 ml/min.1.72m2
- INR >1.8 on no anticoagulation or contraindication to withdrawing anticoagulation
- platelets <100,000/mm3
- History of laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) testing or other commercial or public health assay
Where in United States
- University of Colorado Anschutz Medical CampusAurora, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- Patients with evidence of myocardial injury related to vaccination with a SARS-CoV-2 mRNA vaccine
Patients who present with new symptoms of chest pain within 2-10 days following SARS-CoV-2 mRNA vaccination will be recruited up to 180 days following diagnosis. Patients will be screened using multiple methods and then provided informed consent. If patients are unable to consent, health care decision makers of patients who meet initial inclusion criteria will be approached for consent. Following informed consent, a cardiac MRI will be performed (if not performed prior) to assess myocardial function and potential damage. Patients will qualify on the basis of the presence of late-gadolinium enhancement and/or abnormal T1 mapping on MRI. The patient will then be taken to the cardiac catheterization lab where he/she will undergo endomyocardial biopsy and right heart catheterization (RHC) for candidate gene analysis. A blood sample will be collected to analyze circulating biomarkers associated with myocardial injury.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of Myocardial Dysfunction Due to mRNA-based SARS-CoV-2 Vaccines
- Record updated
- 4 April 2025