Trial Outcomes & Findings for Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis (NCT NCT04326842)

NCT ID: NCT04326842

Last Updated: 2020-10-19

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 129 participants
• Primary outcome timeframe: Difference of vessel density in each group at baseline
• Results posted on: 2020-10-19

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	40	89
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	9	58

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Carotid Artery Stenosis n=31 Participants 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.	Control n=31 Participants 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 n=62 Participants Total of all reporting groups
Age, Continuous	62.68 years STANDARD_DEVIATION 6.82 • n=31 Participants	55.39 years STANDARD_DEVIATION 11.01 • n=31 Participants	59.04 years STANDARD_DEVIATION 8.91 • n=62 Participants
Sex: Female, Male Female	13 Participants n=31 Participants	4 Participants n=31 Participants	17 Participants n=62 Participants
Sex: Female, Male Male	18 Participants n=31 Participants	27 Participants n=31 Participants	45 Participants n=62 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Tobacco	15 Participants n=31 Participants	14 Participants n=31 Participants	29 Participants n=62 Participants
Alcohol	11 Participants n=31 Participants	6 Participants n=31 Participants	17 Participants n=62 Participants
Hypertension	28 Participants n=31 Participants	21 Participants n=31 Participants	49 Participants n=62 Participants
Diabetes	6 Participants n=31 Participants	9 Participants n=31 Participants	15 Participants n=62 Participants

PRIMARY outcome

Timeframe: Difference of vessel density in each group at baseline

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

Outcome measures

Measure	Carotid Artery Stenosis n=31 Participants 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.	Control n=31 Participants 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.
Radical Peripapillary Capillaries Vessel Density	55.95 percentage of vessel Interval 53.3 to 58.1	57.24 percentage of vessel Interval 56.0 to 59.2

PRIMARY outcome

Timeframe: Difference of vessel density in each group at baseline

superficial vascular complexes vessel density of Optical Coherence Tomography Angiography

Outcome measures

Measure	Carotid Artery Stenosis n=31 Participants 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.	Control n=31 Participants 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.
Superficial Vascular Complexes Vessel Density	48.65 percentage of vessel Interval 45.5 to 51.1	52.22 percentage of vessel Interval 50.14 to 52.53

PRIMARY outcome

Timeframe: Difference of vessel density in each group at baseline

deep vascular complexes vessel density of Optical Coherence Tomography Angiography

Outcome measures

Measure	Carotid Artery Stenosis n=31 Participants 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.	Control n=31 Participants 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.
Deep Vascular Complexes Vessel Density	49.65 percentage of vessel Interval 46.5 to 53.7	57.50 percentage of vessel Interval 53.8 to 59.85

PRIMARY outcome

Timeframe: Difference of vessel density in each group at baseline

choriocapillaris vessel density of Optical Coherence Tomography Angiography

Outcome measures

Measure	Carotid Artery Stenosis n=31 Participants 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.	Control n=31 Participants 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.
Choriocapillaris Vessel Density	67.41 percentage of vessel Interval 62.9 to 69.92	68.74 percentage of vessel Interval 65.91 to 71.11

SECONDARY outcome

Timeframe: baseline and 4 days after carotid artery procedure

Population: 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

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.

Outcome measures

Measure	Carotid Artery Stenosis n=14 Participants 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.	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.
Change of Difference of Mean Transit Time(dMTT)	-0.22 seconds Interval -0.46 to -0.16	—

SECONDARY outcome

Timeframe: baseline and 4 days after carotid artery procedure

Population: 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

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.

Outcome measures

Measure	Carotid Artery Stenosis n=14 Participants 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.	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.
Change of the Ratio of Cerebral Blood Flow(rCBF)	0.19 ratio Interval 0.02 to 0.31	—

SECONDARY outcome

Timeframe: baseline and 4 days after carotid artery procedure

Population: 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

changes of retinal nerve fiber layer of Optical Coherence Tomography Angiography

Outcome measures

Measure	Carotid Artery Stenosis n=14 Participants 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.	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.
Changes of Retinal Nerve Fiber Layer	2.50 μm Interval 2.0 to 11.0	—

SECONDARY outcome

Timeframe: baseline and 4 days after carotid artery procedure

Population: 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

changes of deep vascular complexes vessel density of Optical Coherence Tomography Angiography

Outcome measures

Measure	Carotid Artery Stenosis n=14 Participants 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.	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.
Changes of Deep Vascular Complexes Vessel Density	4.00 percentage of vessel Interval 0.7 to 6.5	—

SECONDARY outcome

Timeframe: baseline and 4 days after carotid artery procedure

Population: 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

changes of radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography

Outcome measures

Measure	Carotid Artery Stenosis n=14 Participants 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.	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.
Changes of Radical Peripapillary Capillaries Vessel Density	1.55 percentage of vessel Interval 0.4 to 2.6	—

SECONDARY outcome

Timeframe: baseline and 4 days after carotid artery procedure

Population: 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

changes of superficial vascular complexes vessel density of Optical Coherence Tomography Angiography

Outcome measures

Measure	Carotid Artery Stenosis n=14 Participants 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.	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.
Changes of Superficial Vascular Complexes Vessel Density	1.70 percentage of vessel Interval 0.4 to 2.8	—

Adverse Events

Carotid Artery Stenosis

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Carotid Artery Stenosis n=31 participants at risk 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.	Control n=31 participants at risk Patients without carotid artery stenosis. Examination will be performed using optical coherence tomography angiography. Control group did not undergo carotid artery surgery.
Nervous system disorders Cerebral infarction	3.2% 1/31 • Number of events 1 • 2weeks post-operation A patient developed cerebral infarction 7 days after operation, which resulted in prolongation of existing hospitalization.	0.00% 0/31 • 2weeks post-operation A patient developed cerebral infarction 7 days after operation, which resulted in prolongation of existing hospitalization.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hong Zhang

The First Affiliated Hospital of Harbin Medical University

Phone: +86 0451-85553952

Email: 2315186458@qq.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place