Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT05359250
Eligibility Criteria:
Inclusion Criteria:
1. age ≥18 years;
2. clear evidence of myocardial involvement including:
1. High Sensitivity Troponin I value of (≥0.05 ng/ml (the 99% upper bound)) OR
2. an LVEF \< 50% OR
3. ST-T change suggesting STEMI, NSTEMI or myopericarditis in the absence of coronary artery disease, OR
4. new onset sustained VT or VF
3. Late gadolinium enhancement or edema on cMRI consistent with myocardial injury or inflammation.
4. Documentation of vaccination with mRNA-based COVID-19 vaccine.
5. No history of COVID-19, or a negative SARS-CoV-2 PCR or other FDA approved laboratory test within 1 week of enrollment.
6. Patient and/or legally authorized representative must be competent to understand and agree with informed consent form.
Exclusion Criteria:
1. Hemodynamic instability as evidenced by escalating doses of inotropic agents or vasopressors within the prior 24 hours
2. Respiratory instability as evidenced by increasing oxygen requirements over the 24 hours prior to consent or FiO2 requirement ≥ 60 %.
3. evidence that respiratory failure is the primary reason for myocardial dysfunction;
4. Moderate to severe pulmonary hypertension (mean PAP ≥35 mmHg);
5. INR \>1.8 on no anticoagulation or contraindication to withdrawing anticoagulation;
6. platelets \<100,000/mm3.
7. History of laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) testing or other commercial or public health assay.
8. Acute or chronic kidney disease with glomerular filtration rate \< 30 ml/min.1.72m2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05359250
Study Brief:
Protocol Section:
NCT05359250