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

• Sponsor: First Affiliated Hospital of Harbin Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04326842
• Collaborator: (none)
• Enrollment: 129
• Location: 1
• Actual Duration (Months): 3
• Patients Per Site Per Month: 43.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Stenosis	Procedure: Carotid artery revascularization procedure; Device: Optical coherence tomography angiography

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 129 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis
• Actual Study Start Date: Apr 2, 2020
• Actual Primary Completion Date: Jun 20, 2020
• Actual Study Completion Date: Jul 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Carotid artery stenosis Patients with carotid artery stenosis. Procedure: Carotid artery revascularization procedure	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.
Control Patients without carotid artery stenosis	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.

Outcome Measures

Primary Outcome Measures

1. 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）

2. Superficial Vascular Complexes Vessel Density [Difference of vessel density in each group at baseline]

   superficial vascular complexes vessel density of Optical Coherence Tomography Angiography

3. Deep Vascular Complexes Vessel Density [Difference of vessel density in each group at baseline]

   deep vascular complexes vessel density of Optical Coherence Tomography Angiography

4. Choriocapillaris Vessel Density [Difference of vessel density in each group at baseline]

   choriocapillaris vessel density of Optical Coherence Tomography Angiography

Secondary Outcome Measures

1. 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.

2. 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.

3. 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

4. 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

5. 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

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China

Sponsors and Collaborators

• First Affiliated Hospital of Harbin Medical University

Investigators

• Principal Investigator: Hong Zhang, First Affiliated Hospital of Harbin Medical University
• Principal Investigator: Huaizhang Shi, First Affiliated Hospital of Harbin Medical University

Study Documents (Full-Text)

• Informed Consent Form - Apr 1, 2020
• Study Protocol and Statistical Analysis Plan - Jun 5, 2020

More Information

Publications

None provided.

• Responsible Party: First Affiliated Hospital of Harbin Medical University
• ClinicalTrials.gov Identifier: NCT04326842
• Other Study ID Numbers: HZHZS1
• First Posted: Mar 30, 2020
• Last Update Posted: Oct 19, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by First Affiliated Hospital of Harbin Medical University: Carotid Stenosis; OCTA
• Additional relevant MeSH terms: Carotid Stenosis; Constriction, Pathologic

Study Results

Participant Flow

Arm/Group Title	Carotid Artery Stenosis	Control
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	40	89
COMPLETED	31	31
NOT COMPLETED	9	58

Baseline Characteristics

Arm/Group Title	Carotid Artery Stenosis	Control	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	31	31	62
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.68 (6.82)	55.39 (11.01)	59.04 (8.91)
Sex: Female, Male (Count of Participants)
Female	13 41.9%	4 12.9%	17 27.4%
Male	18 58.1%	27 87.1%	45 72.6%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Tobacco (Count of Participants)
Count of Participants [Participants]	15 48.4%	14 45.2%	29 46.8%
Alcohol (Count of Participants)
Count of Participants [Participants]	11 35.5%	6 19.4%	17 27.4%
Hypertension (Count of Participants)
Count of Participants [Participants]	28 90.3%	21 67.7%	49 79%
Diabetes (Count of Participants)
Count of Participants [Participants]	6 19.4%	9 29%	15 24.2%

Outcome Measures

1. Primary Outcome

Title	Radical Peripapillary Capillaries Vessel Density
Description	Radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography（OCTA）
Time Frame	Difference of vessel density in each group at baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Carotid Artery Stenosis	Control
Arm/Group Description	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.	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.
Measure Participants	31	31
Median (Inter-Quartile Range) [percentage of vessel]	55.95	57.24

2. Primary Outcome

Title	Superficial Vascular Complexes Vessel Density
Description	superficial vascular complexes vessel density of Optical Coherence Tomography Angiography
Time Frame	Difference of vessel density in each group at baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Carotid Artery Stenosis	Control
Arm/Group Description	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.	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.
Measure Participants	31	31
Median (Inter-Quartile Range) [percentage of vessel]	48.65	52.22

3. Primary Outcome

Title	Deep Vascular Complexes Vessel Density
Description	deep vascular complexes vessel density of Optical Coherence Tomography Angiography
Time Frame	Difference of vessel density in each group at baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Carotid Artery Stenosis	Control
Arm/Group Description	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.	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.
Measure Participants	31	31
Median (Inter-Quartile Range) [percentage of vessel]	49.65	57.50

4. Primary Outcome

Title	Choriocapillaris Vessel Density
Description	choriocapillaris vessel density of Optical Coherence Tomography Angiography
Time Frame	Difference of vessel density in each group at baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Carotid Artery Stenosis	Control
Arm/Group Description	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.	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.
Measure Participants	31	31
Median (Inter-Quartile Range) [percentage of vessel]	67.41	68.74

5. Secondary Outcome

Title	Change of Difference of Mean Transit Time(dMTT)
Description	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.
Time Frame	baseline and 4 days after carotid artery procedure

Outcome Measure Data

Analysis Population Description

This Outcome Measure was only assessed in the "Carotid Artery Stenosis" Arm/Group Among the 31 patients in the experimental group, 21 patients had unilateral severe stenosis or occlusion and 7 patients dropped out of the study

Arm/Group Title	Carotid Artery Stenosis
Arm/Group Description	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.
Measure Participants	14
Median (Inter-Quartile Range) [seconds]	-0.22

6. Secondary Outcome

Title	Change of the Ratio of Cerebral Blood Flow(rCBF)
Description	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.
Time Frame	baseline and 4 days after carotid artery procedure

Outcome Measure Data

Analysis Population Description

This Outcome Measure was only assessed in the "Carotid Artery Stenosis" Arm/Group Among the 31 patients in the experimental group, 21 patients had unilateral severe stenosis or occlusion and 7 patients dropped out of the study

Arm/Group Title	Carotid Artery Stenosis
Arm/Group Description	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.
Measure Participants	14
Median (Inter-Quartile Range) [ratio]	0.19

7. Secondary Outcome

Title	Changes of Retinal Nerve Fiber Layer
Description	changes of retinal nerve fiber layer of Optical Coherence Tomography Angiography
Time Frame	baseline and 4 days after carotid artery procedure

Outcome Measure Data

Analysis Population Description

This Outcome Measure was only assessed in the "Carotid Artery Stenosis" Arm/Group Among the 31 patients in the experimental group, 21 patients had unilateral severe stenosis or occlusion and 7 patients dropped out of the study

Arm/Group Title	Carotid Artery Stenosis
Arm/Group Description	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.
Measure Participants	14
Median (Inter-Quartile Range) [μm]	2.50

8. Secondary Outcome

Title	Changes of Deep Vascular Complexes Vessel Density
Description	changes of deep vascular complexes vessel density of Optical Coherence Tomography Angiography
Time Frame	baseline and 4 days after carotid artery procedure

Outcome Measure Data

Analysis Population Description

This Outcome Measure was only assessed in the "Carotid Artery Stenosis" Arm/Group Among the 31 patients in the experimental group, 21 patients had unilateral severe stenosis or occlusion and 7 patients dropped out of the study

Arm/Group Title	Carotid Artery Stenosis
Arm/Group Description	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.
Measure Participants	14
Median (Inter-Quartile Range) [percentage of vessel]	4.00

9. Secondary Outcome

Title	Changes of Radical Peripapillary Capillaries Vessel Density
Description	changes of radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography
Time Frame	baseline and 4 days after carotid artery procedure

Outcome Measure Data

Analysis Population Description

This Outcome Measure was only assessed in the "Carotid Artery Stenosis" Arm/Group Among the 31 patients in the experimental group, 21 patients had unilateral severe stenosis or occlusion and 7 patients dropped out of the study

Arm/Group Title	Carotid Artery Stenosis
Arm/Group Description	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.
Measure Participants	14
Median (Inter-Quartile Range) [percentage of vessel]	1.55

10. Secondary Outcome

Title	Changes of Superficial Vascular Complexes Vessel Density
Description	changes of superficial vascular complexes vessel density of Optical Coherence Tomography Angiography
Time Frame	baseline and 4 days after carotid artery procedure

Outcome Measure Data

Analysis Population Description

This Outcome Measure was only assessed in the "Carotid Artery Stenosis" Arm/Group Among the 31 patients in the experimental group, 21 patients had unilateral severe stenosis or occlusion and 7 patients dropped out of the study

Arm/Group Title	Carotid Artery Stenosis
Arm/Group Description	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.
Measure Participants	14
Median (Inter-Quartile Range) [percentage of vessel]	1.70

Adverse Events

Time Frame	2weeks post-operation
Adverse Event Reporting Description	A patient developed cerebral infarction 7 days after operation, which resulted in prolongation of existing hospitalization.
Arm/Group Title	Carotid Artery Stenosis		Control
Arm/Group Description	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.		Patients without carotid artery stenosis. Examination will be performed using optical coherence tomography angiography. Control group did not undergo carotid artery surgery.
All Cause Mortality
	Carotid Artery Stenosis		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/31 (0%)
Serious Adverse Events
	Carotid Artery Stenosis		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/31 (3.2%)		0/31 (0%)
Nervous system disorders
Cerebral infarction	1/31 (3.2%)	1	0/31 (0%)	0
Other (Not Including Serious) Adverse Events
	Carotid Artery Stenosis		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.