Influence of COVID-19 on Vascular Endothelial Function (COVAS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID; Vascular; Damage
• Intervention / Treatment: Diagnostic test: Carotid Artery Reactivity Testing

• Study Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• Netherlands
  • Uden, Netherlands, 5406 PT
    • Bernhoven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with past COVID-19 infection will be recruited at Bernhoven hospital, the Netherlands.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Bernhoven Hospital
• Investigators: Principal Investigator: Andre S van Petersen, PhD, Benhoven

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Anticipated): March 30, 2022
• Study Completion (Anticipated): March 30, 2022

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: NL2020-6555

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No