Clinical trial NCT04326842: Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis
Official title: Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Stenosis
Keywords: Carotid Stenosis
OCTA
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with carotid artery stenosis undergoing cerebral and eye examination and in routine clinical practice will be included

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Radical Peripapillary Capillaries Vessel Density
timeFrame: Difference of vessel density in each group at baseline
measure: Superficial Vascular Complexes Vessel Density
timeFrame: Difference of vessel density in each group at baseline
measure: Deep Vascular Complexes Vessel Density
timeFrame: Difference of vessel density in each group at baseline
measure: Choriocapillaris Vessel Density
timeFrame: Difference of vessel density in each group at baseline
Secondary outcomes:
measure: Change of Difference of Mean Transit Time(dMTT)
timeFrame: baseline and 4 days after carotid artery procedure
measure: Change of the Ratio of Cerebral Blood Flow(rCBF)
timeFrame: baseline and 4 days after carotid artery procedure
measure: Changes of Retinal Nerve Fiber Layer
timeFrame: baseline and 4 days after carotid artery procedure
measure: Changes of Deep Vascular Complexes Vessel Density
timeFrame: baseline and 4 days after carotid artery procedure
measure: Changes of Radical Peripapillary Capillaries Vessel Density
timeFrame: baseline and 4 days after carotid artery procedure
measure: Changes of Superficial Vascular Complexes Vessel Density
timeFrame: baseline and 4 days after carotid artery procedure
Other outcomes:
Locations:
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: First Affiliated Hospital of Harbin Medical University
name: Hong Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Harbin Medical University
name: Huaizhang Shi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.