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

NCT04326842 | Completed Results FDA Device

• 1 other identifier: HZHZS1
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Stenosis

Keywords

Carotid Stenosis; OCTA

Outcome Measures

Primary Outcomes (4)

• Radical Peripapillary Capillaries Vessel Density

  Radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography（OCTA）

  Difference of vessel density in each group at baseline

• Superficial Vascular Complexes Vessel Density

  superficial vascular complexes vessel density of Optical Coherence Tomography Angiography

  Difference of vessel density in each group at baseline

• Deep Vascular Complexes Vessel Density

  deep vascular complexes vessel density of Optical Coherence Tomography Angiography

  Difference of vessel density in each group at baseline

• Choriocapillaris Vessel Density

  choriocapillaris vessel density of Optical Coherence Tomography Angiography

  Difference of vessel density in each group at baseline

Secondary Outcomes (6)

• Change of Difference of Mean Transit Time(dMTT)

  baseline and 4 days after carotid artery procedure

• Change of the Ratio of Cerebral Blood Flow(rCBF)

  baseline and 4 days after carotid artery procedure

• Changes of Retinal Nerve Fiber Layer

  baseline and 4 days after carotid artery procedure

• Changes of Deep Vascular Complexes Vessel Density

  baseline and 4 days after carotid artery procedure

• Changes of Radical Peripapillary Capillaries Vessel Density

  baseline and 4 days after carotid artery procedure

Study Arms (2)

Carotid artery stenosis

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

Procedure: Carotid artery revascularization procedure; Device: Optical coherence tomography angiography

Control

Patients without carotid artery stenosis

Device: Optical coherence tomography angiography

Interventions

Carotid artery revascularization procedure PROCEDURE

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

Carotid artery stenosis

Optical coherence tomography angiography 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.

Carotid artery stenosis; Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with carotid artery stenosis undergoing cerebral and eye examination and in routine clinical practice will be included

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

Related Publications (1)

• 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.

  PMID: 34326905 DERIVED

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Hong Zhang
• Organization: The First Affiliated Hospital of Harbin Medical University

2315186458@qq.com

+86 0451-85553952

Study Officials

• Hong Zhang

  First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

• Huaizhang Shi

  First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 30, 2020
• Study Start: April 2, 2020
• Primary Completion: June 20, 2020
• Study Completion: July 2, 2020
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-04

Locations

CN (1)