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

Carotid Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04326842
• Other study ID #: HZHZS1
• Status: Completed
• Start date: April 2, 2020
• Est. completion date: July 2, 2020

Study information

• Verified date: April 2020
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: July 2, 2020
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Carotid Stenosis
• Constriction, Pathologic

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Superficial Vascular Complexes Vessel Density	superficial vascular complexes vessel density of Optical Coherence Tomography Angiography	Difference of vessel density in each group at baseline
Primary	Deep Vascular Complexes Vessel Density	deep vascular complexes vessel density of Optical Coherence Tomography Angiography	Difference of vessel density in each group at baseline
Primary	Choriocapillaris Vessel Density	choriocapillaris vessel density of Optical Coherence Tomography Angiography	Difference of vessel density in each group at baseline
Secondary	Change of Difference of Mean Transit Time(dMTT)	Change of dMTT is the dMTT value at 4 days after carotid artery procedure minus the value at baseline.; dMTT is that the value of the lesion side minus value of contralateral side. Mean transit time (MTT) corresponds to the average time, in seconds, that red blood cells spend within a determinate volume of capillary circulation.	baseline and 4 days after carotid artery procedure
Secondary	Change of the Ratio of Cerebral Blood Flow(rCBF)	Change of rCBF is the rCBF value at 4 days after carotid artery procedure minus the value at baseline.; rCBF is that the CBF value of the lesion side divided by the value of contralateral side.; CBF refers to the flow of blood through a certain cross-sectional area of cerebrovascular per unit time.	baseline and 4 days after carotid artery procedure
Secondary	Changes of Retinal Nerve Fiber Layer	changes of retinal nerve fiber layer of Optical Coherence Tomography Angiography	baseline and 4 days after carotid artery procedure
Secondary	Changes of Deep Vascular Complexes Vessel Density	changes of deep vascular complexes vessel density of Optical Coherence Tomography Angiography	baseline and 4 days after carotid artery procedure
Secondary	Changes of Radical Peripapillary Capillaries Vessel Density	changes of radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography	baseline and 4 days after carotid artery procedure
Secondary	Changes of Superficial Vascular Complexes Vessel Density	changes of superficial vascular complexes vessel density of Optical Coherence Tomography Angiography	baseline and 4 days after carotid artery procedure