Influence of COVID-19 on Vascular Endothelial Function

NCT ID: NCT04468412

Last Updated: 2022-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-14

Study Completion Date

2022-03-30

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.

Detailed Description

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Conditions

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COVID Vascular; Damage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Cold pressor test

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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bernhoven Hospital

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michiel C Warle, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Andre S van Petersen, PhD

Role: PRINCIPAL_INVESTIGATOR

Benhoven

Locations

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Bernhoven

Uden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL2020-6555

Identifier Type: -

Identifier Source: org_study_id

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