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Myocardial Virus and Gene Expression in SARS CoV-2 Positive Patients ?with Clinically Important Myocardial Dysfunction

Study category: Heart and Blood Conditions

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Description

This study plans to learn more about coronavirus infection in the heart. We wish to investigate whether the coronavirus that causes COVID-19 directly infects heart muscle tissue, and if so, how this might occur. The hope is that once we better understand how this process occurs, that we may be able to develop or utilize drugs to treat this process. Patients are being asked to be in this research study because they have coronavirus causing COVID-19 infection and have signs that is impacting your heart.

Main Procedures Involved: - Echocardiogram - Heart Function Assessment - Blood Draws - Heart Biopsy

Duration of Participation: Approximately 2-weeks

Details
Age

18 to 89 years

Eligibility

Ten patients with PCR confirmed CoV-2 infection and evidence of cardiac involvement contributing to clinical compromise will be recruited from the UCH ICU and inpatient hospital units. Patients will have no other known etiology for cardiomyopathy other than COVID-19 infection. Patients may be supported with mechanical ventilation but will need to be in a stable respiratory condition with improving oxygen requirements prior to enrollment. In addition, investigators will have direct conversations with the treating ICU or Hospitalist team caring for the patient on the day prior to and day of the procedure to review the status of the patient and ensure no acute changes have occurred that may increase the risk of transportation out of the unit. Additional Inclusion criteria include: 1) age >18 years; 2) clear evidence of myocardial involvement including a Troponin I value of (≥0.05 ng/ml (the 99% upper bound)) AND a) an LVEF < 50% OR b) a global longitudinal strain of > -16.0, OR c) ST-T change suggesting STEMI, NSTEMI or myopericarditis in the presence of patent coronary arteries, OR d) new onset sustained VT or VF 3) Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) testing or other commercial or public health assay 4) 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 <100k/mm3.

Type of Study

Diagnostic

Compensation

0

Travel Compensation

0

Location

University of Colorado Hospital

Principal Investigator
Natasha Altman,  MD

Natasha Altman, MD

Study ID

Protocol Number: 20-0852

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