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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carotid artery stenosis | Patients with carotid artery stenosis. Procedure: Carotid artery revascularization procedure |
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| Control | Patients without carotid artery stenosis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotid artery revascularization procedure | Procedure | The patients with carotid artery stenosis will be examined before and after finishing the carotid artery revascularization procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with carotid artery stenosis undergoing cerebral and eye examination and in routine clinical practice will be included
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| Name | Affiliation | Role |
|---|---|---|
| Hong Zhang | First Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Huaizhang Shi | First Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34326905 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2020 | Jul 6, 2020 |
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| 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. |
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| FG001 | 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Tobacco | Count of Participants | Participants |
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| Alcohol | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
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| Diabetes | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Radical Peripapillary Capillaries Vessel Density | Radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography（OCTA） | Posted | Median | Inter-Quartile Range | percentage of vessel | Difference of vessel density in each group at baseline |
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| Primary | Superficial Vascular Complexes Vessel Density | superficial vascular complexes vessel density of Optical Coherence Tomography Angiography | Posted | Median | Inter-Quartile Range | percentage of vessel | Difference of vessel density in each group at baseline |
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| Primary | Deep Vascular Complexes Vessel Density | deep vascular complexes vessel density of Optical Coherence Tomography Angiography | Posted | Median | Inter-Quartile Range | percentage of vessel | Difference of vessel density in each group at baseline |
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| Primary | Choriocapillaris Vessel Density | choriocapillaris vessel density of Optical Coherence Tomography Angiography | Posted | Median | Inter-Quartile Range | percentage of vessel | Difference of vessel density in each group at baseline |
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| 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. | 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 | Posted | Median | Inter-Quartile Range | seconds | baseline and 4 days after carotid artery procedure |
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| 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. | 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 | Posted | Median | Inter-Quartile Range | ratio | baseline and 4 days after carotid artery procedure |
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| Secondary | Changes of Retinal Nerve Fiber Layer | changes of retinal nerve fiber layer of Optical Coherence Tomography Angiography | 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 | Posted | Median | Inter-Quartile Range | μm | baseline and 4 days after carotid artery procedure |
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| Secondary | Changes of Deep Vascular Complexes Vessel Density | changes of deep vascular complexes vessel density of Optical Coherence Tomography Angiography | 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 | Posted | Median | Inter-Quartile Range | percentage of vessel | baseline and 4 days after carotid artery procedure |
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| Secondary | Changes of Radical Peripapillary Capillaries Vessel Density | changes of radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography | 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 | Posted | Median | Inter-Quartile Range | percentage of vessel | baseline and 4 days after carotid artery procedure |
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| Secondary | Changes of Superficial Vascular Complexes Vessel Density | changes of superficial vascular complexes vessel density of Optical Coherence Tomography Angiography | 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 | Posted | Median | Inter-Quartile Range | percentage of vessel | baseline and 4 days after carotid artery procedure |
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2weeks post-operation
A patient developed cerebral infarction 7 days after operation, which resulted in prolongation of existing hospitalization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 31 | 1 | 31 | 0 | 31 |
| EG001 | Control | Patients without carotid artery stenosis. Examination will be performed using optical coherence tomography angiography. Control group did not undergo carotid artery surgery. | 0 | 31 | 0 | 31 | 0 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral infarction | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hong Zhang | The First Affiliated Hospital of Harbin Medical University | +86 0451-85553952 | 2315186458@qq.com |
| ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2020 | Aug 15, 2020 | Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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