Influence of COVID-19 on Vascular Endothelial Function

COVID Clinical Trial

— COVAS  

Official title:

Influence of COVID-19 on Vascular Endothelial Function

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04468412
• Other study ID #: NL2020-6555
• Status: Active, not recruiting
• Start date: July 14, 2020
• Est. completion date: March 30, 2022

Study information

• Verified date: September 2021
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 203
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID
• Vascular; Damage

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Netherlands	Bernhoven	Uden

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Bernhoven Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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