- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04326842
Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Heilongjiang
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Harbin, Heilongjiang, China
- The First Affiliated Hospital of Harbin Medical University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Radical Peripapillary Capillaries Vessel Density
Prazo: 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
Prazo: 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
|
|
Deep Vascular Complexes Vessel Density
Prazo: Difference of vessel density in each group at baseline
|
deep vascular complexes vessel density of Optical Coherence Tomography Angiography
|
Difference of vessel density in each group at baseline
|
|
Choriocapillaris Vessel Density
Prazo: Difference of vessel density in each group at baseline
|
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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change of Difference of Mean Transit Time(dMTT)
Prazo: 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
|
|
Change of the Ratio of Cerebral Blood Flow(rCBF)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Investigadores
- Investigador principal: Hong Zhang, First Affiliated Hospital of Harbin Medical University
- Investigador principal: Huaizhang Shi, First Affiliated Hospital of Harbin Medical University
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
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Outros números de identificação do estudo
- HZHZS1
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