Influence of COVID-19 on Vascular Endothelial Function

• Conditions: COVID; Vascular; Damage

• Registration Number: NCT04468412
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-13
• Study Start: 2020-07-14
• Status Verified: 2021-09
• Last Update Submitted: 2022-01-17
• Last Update Posted: 2022-01-19
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 203

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bernhoven; 🇳🇱 Uden, Netherlands