Influence of COVID-19 on Vascular Endothelial Function

NCT04468412 | Unknown

• 1 other identifier: NL2020-6555
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID; Vascular; Damage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Major adverse cardiovascular events (MACE)

  1 year

Interventions

Carotid Artery Reactivity Testing DIAGNOSTIC_TEST

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.

Also known as: Cold pressor test

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Bernhoven Hospital: collaborator

Study Sites (1)

Bernhoven

Uden, 5406 PT, Netherlands

Location

Study Officials

• Michiel C Warle, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Andre S van Petersen, PhD

  Benhoven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 13, 2020
• Study Start: July 14, 2020
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: January 19, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)