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Clinical Trials/NCT04468412
NCT04468412
Unknown
Not Applicable

Influence of COVID-19 on Vascular Endothelial Function

Radboud University Medical Center1 site in 1 country203 target enrollmentJuly 14, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID
Sponsor
Radboud University Medical Center
Enrollment
203
Locations
1
Primary Endpoint
Endothelial dysfunction
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 14, 2020
End Date
March 30, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Endothelial dysfunction

Time Frame: 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)

Study Sites (1)

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