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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04326842

Enrollment

129

Registered

2020-03-30

Start date

2020-04-02

Completion date

2020-07-02

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Stenosis

Keywords

Carotid Stenosis, OCTA

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.

Interventions

PROCEDURECarotid artery revascularization procedure

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

DEVICEOptical 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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
Radical Peripapillary Capillaries Vessel Density	Difference of vessel density in each group at baseline	Radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography（OCTA）
Superficial Vascular Complexes Vessel Density	Difference of vessel density in each group at baseline	superficial vascular complexes vessel density of Optical Coherence Tomography Angiography
Deep Vascular Complexes Vessel Density	Difference of vessel density in each group at baseline	deep vascular complexes vessel density of Optical Coherence Tomography Angiography
Choriocapillaris Vessel Density	Difference of vessel density in each group at baseline	choriocapillaris vessel density of Optical Coherence Tomography Angiography

Secondary

Measure	Time frame	Description
Changes of Radical Peripapillary Capillaries Vessel Density	baseline and 4 days after carotid artery procedure	changes of radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography
Change of Difference of Mean Transit Time(dMTT)	baseline and 4 days after carotid artery procedure	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.
Changes of Superficial Vascular Complexes Vessel Density	baseline and 4 days after carotid artery procedure	changes of superficial vascular complexes vessel density of Optical Coherence Tomography Angiography
Change of the Ratio of Cerebral Blood Flow(rCBF)	baseline and 4 days after carotid artery procedure	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.
Changes of Retinal Nerve Fiber Layer	baseline and 4 days after carotid artery procedure	changes of retinal nerve fiber layer of Optical Coherence Tomography Angiography
Changes of Deep Vascular Complexes Vessel Density	baseline and 4 days after carotid artery procedure	changes of deep vascular complexes vessel density of Optical Coherence Tomography Angiography

Countries

China

Participant flow

Participants by arm

Arm	Count
Carotid Artery Stenosis Patients with carotid artery stenosis. Procedure: Carotid artery revascularization procedure Carotid artery revascularization procedure: The patients with carotid artery stenosis will be examined before and after finishing the carotid artery revascularization 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.	31
Control Patients without carotid artery stenosis 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.	31
Total	62

Baseline characteristics

Characteristic	Control	Total	Carotid Artery Stenosis
Age, Continuous	55.39 years STANDARD_DEVIATION 11.01	59.04 years STANDARD_DEVIATION 8.91	62.68 years STANDARD_DEVIATION 6.82
Alcohol	6 Participants	17 Participants	11 Participants
Diabetes	9 Participants	15 Participants	6 Participants
Hypertension	21 Participants	49 Participants	28 Participants
Race and Ethnicity Not Collected	—	0 Participants	—
Sex: Female, Male Female	4 Participants	17 Participants	13 Participants
Sex: Female, Male Male	27 Participants	45 Participants	18 Participants
Tobacco	14 Participants	29 Participants	15 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 31	0 / 31
other Total, other adverse events	0 / 31	0 / 31
serious Total, serious adverse events	1 / 31	0 / 31

Outcome results

Primary

Choriocapillaris Vessel Density

choriocapillaris vessel density of Optical Coherence Tomography Angiography

Time frame: Difference of vessel density in each group at baseline

Arm	Measure	Value (MEDIAN)
Carotid Artery Stenosis	Choriocapillaris Vessel Density	67.41 percentage of vessel
Control	Choriocapillaris Vessel Density	68.74 percentage of vessel

Primary

Deep Vascular Complexes Vessel Density

deep vascular complexes vessel density of Optical Coherence Tomography Angiography

Time frame: Difference of vessel density in each group at baseline

Arm	Measure	Value (MEDIAN)
Carotid Artery Stenosis	Deep Vascular Complexes Vessel Density	49.65 percentage of vessel
Control	Deep Vascular Complexes Vessel Density	57.50 percentage of vessel

Primary

Radical Peripapillary Capillaries Vessel Density

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

Time frame: Difference of vessel density in each group at baseline

Arm	Measure	Value (MEDIAN)
Carotid Artery Stenosis	Radical Peripapillary Capillaries Vessel Density	55.95 percentage of vessel
Control	Radical Peripapillary Capillaries Vessel Density	57.24 percentage of vessel

Primary

Superficial Vascular Complexes Vessel Density

superficial vascular complexes vessel density of Optical Coherence Tomography Angiography

Time frame: Difference of vessel density in each group at baseline

Arm	Measure	Value (MEDIAN)
Carotid Artery Stenosis	Superficial Vascular Complexes Vessel Density	48.65 percentage of vessel
Control	Superficial Vascular Complexes Vessel Density	52.22 percentage of vessel

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.