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

NCT ID: NCT04326842

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 129 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-02
• Study Completion Date: 2020-07-02

Brief Summary

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.

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.

Conditions

Carotid Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Carotid artery stenosis

Patients with carotid artery stenosis. Procedure: Carotid artery revascularization procedure

Carotid artery revascularization procedure

Intervention Type: PROCEDURE

The patients with carotid artery stenosis will be examined before and after finishing the carotid artery revascularization procedure.

Optical coherence tomography angiography

Intervention Type: DEVICE

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.

Control

Patients without carotid artery stenosis

Optical coherence tomography angiography

Intervention Type: DEVICE

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.

Interventions

Carotid artery revascularization procedure

The patients with carotid artery stenosis will be examined before and after finishing the carotid artery revascularization procedure.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• age <18 years
• intraocular pressure (IOP) >21 mmHg
• VA >logMAR 1.0
• spherical equivalent (SE) between >1.00 or < -6.00 D
• other serious eye diseases which may affect OCTA results including diabetic retinopathy, hypertensive retinopathy, retinal vascular occlusion, age-related macular degeneration, and uveitis
• major intraocular surgery performed in the past 6 months or a history of laser photocoagulation or intravitreal injection
• glaucoma or first-degree relatives with a history of glaucoma; and
• any disease that might cause poor scan quality (image quality <6).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hong Zhang

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Harbin Medical University

Huaizhang Shi

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Harbin Medical University

Locations

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Countries

China

References

Li X, Zhu S, Zhou S, Zhang Y, Ding Y, Zheng B, Wu P, Shi Y, Zhang H, Shi H. Optical Coherence Tomography Angiography as a Noninvasive Assessment of Cerebral Microcirculatory Disorders Caused by Carotid Artery Stenosis. Dis Markers. 2021 Jul 5;2021:2662031. doi: 10.1155/2021/2662031. eCollection 2021.

Reference Type: DERIVED

PMID: 34326905 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HZHZS1

Identifier Type: -

Identifier Source: org_study_id