Status:
COMPLETED
Myocardial Injury and Dysfunction Associated With COVID-19 Vaccination
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
American Heart Association
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Myocardial Injury
COVID-19
Eligibility:
All Genders
18+ years
Brief 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 wi...
Detailed Description
To determine whether there is microvascular thrombosis-associated myocardial damage and dysfunction vs. inflammation or other changes in patients who, following administration of SARS-CoV-2 mRNA vacci...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
- Acute or chronic kidney disease with glomerular filtration rate \< 30 ml/min.1.72m2
Key Trial Info
Start Date :
May 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05359250
Start Date
May 12 2021
End Date
December 30 2024
Last Update
April 4 2025
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045