- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04326842
Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Heilongjiang
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Harbin, Heilongjiang, 중국
- The First Affiliated Hospital of Harbin Medical University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Carotid artery stenosis
Patients with carotid artery stenosis.
Procedure: Carotid artery revascularization procedure
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The patients with carotid artery stenosis will be examined before and after finishing the carotid artery revascularization procedure.
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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Control
Patients without carotid artery stenosis
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Radical Peripapillary Capillaries Vessel Density
기간: Difference of vessel density in each group at baseline
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Radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography(OCTA)
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Difference of vessel density in each group at baseline
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Superficial Vascular Complexes Vessel Density
기간: Difference of vessel density in each group at baseline
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superficial vascular complexes vessel density of Optical Coherence Tomography Angiography
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Difference of vessel density in each group at baseline
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Deep Vascular Complexes Vessel Density
기간: Difference of vessel density in each group at baseline
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deep vascular complexes vessel density of Optical Coherence Tomography Angiography
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Difference of vessel density in each group at baseline
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Choriocapillaris Vessel Density
기간: Difference of vessel density in each group at baseline
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choriocapillaris vessel density of Optical Coherence Tomography Angiography
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Difference of vessel density in each group at baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change of Difference of Mean Transit Time(dMTT)
기간: baseline and 4 days after carotid artery procedure
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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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Change of the Ratio of Cerebral Blood Flow(rCBF)
기간: baseline and 4 days after carotid artery procedure
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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
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Changes of Retinal Nerve Fiber Layer
기간: baseline and 4 days after carotid artery procedure
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changes of retinal nerve fiber layer of Optical Coherence Tomography Angiography
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baseline and 4 days after carotid artery procedure
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Changes of Deep Vascular Complexes Vessel Density
기간: baseline and 4 days after carotid artery procedure
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changes of deep vascular complexes vessel density of Optical Coherence Tomography Angiography
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baseline and 4 days after carotid artery procedure
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Changes of Radical Peripapillary Capillaries Vessel Density
기간: baseline and 4 days after carotid artery procedure
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changes of radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography
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baseline and 4 days after carotid artery procedure
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Changes of Superficial Vascular Complexes Vessel Density
기간: baseline and 4 days after carotid artery procedure
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changes of superficial vascular complexes vessel density of Optical Coherence Tomography Angiography
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baseline and 4 days after carotid artery procedure
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hong Zhang, First Affiliated Hospital of Harbin Medical University
- 수석 연구원: Huaizhang Shi, First Affiliated Hospital of Harbin Medical University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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