Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis

Overview

This study aims to evaluate ocular changes in patients with carotid artery stenosis by optical coherence tomography angiography before and after carotid artery revascularization procedure.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 30, 2021

Detailed Description

A growing body of research indicates that abnormal ocular microvascular features may serve as a novel biomarker reflecting the severity of underlying cardiovascular, neurodegenerative, and microvascular disease. Since blood flow to the retina is predominantly supplied by the internal carotid artery (ICA), we hypothesized that ocular microvasculature and structure changes may reflect the disease status or therapeutic effects in patients with carotid artery stenosis.

Optical coherence tomography angiography (OCTA) is a novel, non-invasive imaging modality that can be a reliable tool for the qualitative and quantitative assessments of ocular vessels during various ocular pathological or physiological changes. Recent studies have also demonstrated the ability of OCTA to quantify retinal microvascular changes in monitoring cardiovascular risk.

This study aims to evaluate ocular changes in patients with carotid artery stenosis by optical coherence tomography angiography before and after carotid artery revascularization procedure.In this study, the patients with carotid artery stenosis and control group will receive a series of cerebral and ocular examinations including the most important cerebral CT perfusion (CTP) and OCTA. After that, the cerebral and ocular data between the two groups will be compared. Also, the preoperative and postoperative data acquired will be compared.

Interventions

  • Procedure: Carotid artery revascularization procedure
    • The patients with carotid artery stenosis will be examined before and after finishing the carotid artery revascularization procedure.
  • Device: Optical coherence tomography angiography
    • Examination will be performed using optical coherence tomography angiography. This device allows quantitative analysis, since it provides numerical data about flow area and flow density maps.

Arms, Groups and Cohorts

  • Carotid artery stenosis
    • Patients with carotid artery stenosis. Procedure: Carotid artery revascularization procedure
  • Control
    • Patients without carotid artery stenosis

Clinical Trial Outcome Measures

Primary Measures

  • Vessel density
    • Time Frame: Difference of vessel density in each group at baseline
    • Vessel density of OCTA examination
  • Vessel density
    • Time Frame: Changes at 4 days after carotid artery procedure
    • Vessel density of OCTA examination
  • Vessel density
    • Time Frame: Changes at 3 months after carotid artery procedure
    • Vessel density of OCTA examination
  • Vessel density
    • Time Frame: Changes at 1 year after carotid artery procedure
    • Vessel density of OCTA examination
  • Ocular structural parameters
    • Time Frame: Difference of ocular structural parameters in each group at baseline
    • Ocular structural parameters of OCTA
  • Ocular structural parameters
    • Time Frame: Changes at 4 days after carotid artery procedure
    • Ocular structural parameters of OCTA
  • Ocular structural parameters
    • Time Frame: Changes at 3 months after carotid artery procedure
    • Ocular structural parameters of OCTA
  • Ocular structural parameters
    • Time Frame: Changes at 1 year after carotid artery procedure
    • Ocular structural parameters of OCTA
  • Cerebral perfusion
    • Time Frame: Difference of cerebral perfusion in each group at baseline
    • CTP will be used to detect cerebral perfusion in carotid artery stenosis
  • Cerebral perfusion
    • Time Frame: Changes at 4 days after carotid artery procedure
    • CTP will be used to detect cerebral perfusion in carotid artery stenosis
  • Cerebral perfusion
    • Time Frame: Changes at 3 months after carotid artery procedure
    • CTP will be used to detect cerebral perfusion in carotid artery stenosis
  • Cerebral perfusion
    • Time Frame: Changes at 1 year after carotid artery procedure
    • CTP will be used to detect cerebral perfusion in carotid artery stenosis

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of carotid artery stenosis
  • Age-gender-race-matched controls

Exclusion Criteria

  • Unable to complete cerebral CTP or OCTA examination
  • Severe corneal leukoplakia, cataract, retinal disease, strabismus, nystagmus and other reasons leading to low OCTA image quality (quality<6)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • First Affiliated Hospital of Harbin Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hong Zhang, Principal Investigator, First Affiliated Hospital of Harbin Medical University
    • Huaizhang Shi, Principal Investigator, First Affiliated Hospital of Harbin Medical University
  • Overall Contact(s)
    • Sujun Zhou, +86 18704616237, 2315186458@qq.com

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