Influence of COVID-19 on Vascular Endothelial Function

Study Overview
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Brief Summary
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Rationale: Infection with severe acute respiratory syndrome coronavirus (SARS-CoV) 2 could result in endothelial dysfunction with increased risk of arterial thrombotic events by downregulating the expression of angiotensin converting enzyme 2 (ACE2). Endothelial function can be easily and non-invasively determined by carotid artery reactivity (CAR) testing. Objective: To investigate the predictive value of endothelial dysfunction, measured by carotid artery reactivity testing, for 1-year cardiovascular events in patients with past COVID-19 infection. Study design: A prospective observational longitudinal cohort study. Study population: Patients recovered from confirmed infection with SARS-CoV2. Main study parameters/endpoints: macrovascular endothelial function measured by carotid artery reactivity testing.

Official Title
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Influence of COVID-19 on Vascular Endothelial Function

Conditions
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COVID, Vascular; Damage

Intervention / Treatment
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* Diagnostic Test: Carotid Artery Reactivity Testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed SARS-CoV2 infection by polymerase chain reaction on nasopharyngeal swab, sputum or bronchoalveolar lavage. At least 6 and no more than 20 weeks after resolution of COVID-19 related symptoms ≥ 16 years old Exclusion Criteria: Recent (<3 months) angina pectoris, myocardial infarction, stroke, or heart failure Raynaud syndrome, scleroderma, complex regional pain syndrome of the upper extremity or presence of arteriovenous fistula or open wounds on both the upper extremities.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Carotid Artery Reactivity Testing|The carotid artery reactivity (CAR) test assesses macrovascular endothelial function by measuring the carotid artery diameter in response to sympathetic stimulation. Participants are in the supine position with the neck extended for assessment of the carotid artery. Left carotid artery diameter is recorded continuously during baseline (30 seconds) and during immersion of the right hand up to the wrist in icy water (4°C) for 3 minutes. CAR can either represent a dilatory response (normal endothelial function) or a constrictive response (endothelial dysfunction) of the carotid artery.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial dysfunction | Change in endothelial dysfunction as determined by CAR test. | CAR will be measures between 6 and 20 weeks and 1 year after recovery from COVID-19. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events (MACE) | MACE include non-fatal myocardial infarction, non-fatal ischemic stroke, acute limb ischemia, need for revascularization, amputation and cardiovascular death. | 1 year |