Influence of COVID-19 on Vascular Endothelial Function

NCT04468412 — Unknown, 203 participants, Radboud University Medical Center

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Registry	NCT04468412, acronym COVAS
Status	Unknown
Study type	Observational
Enrollment	203 (Actual)
Sponsor	Radboud University Medical Center (Other); collaborators: Bernhoven Hospital
Conditions	COVID, Vascular; Damage
Interventions	Carotid Artery Reactivity Testing (Diagnostic test)
Dates	start 2020-07-14, primary completion 2022-03-30 (estimated), completion 2022-03-30 (estimated), first posted 2020-07-13, last updated 2022-01-19
Locations	1 site in Netherlands

-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.

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+Arms and interventions

Carotid Artery Reactivity Testing (Diagnostic test), also known as Cold pressor 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.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 16 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Bernhoven	Uden	Netherlands

+Investigators

Michiel C Warle, PhD, Principal investigator, Radboud University Medical Center
Andre S van Petersen, PhD, Principal investigator, Benhoven

My Notes

Public

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