- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04326842
Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Heilongjiang
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Harbin, Heilongjiang, Chiny
- The First Affiliated Hospital of Harbin Medical University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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).
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Radical Peripapillary Capillaries Vessel Density
Ramy czasowe: 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
Ramy czasowe: Difference of vessel density in each group at baseline
|
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
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change of Difference of Mean Transit Time(dMTT)
Ramy czasowe: baseline and 4 days after carotid artery procedure
|
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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: baseline and 4 days after carotid artery procedure
|
changes of deep vascular complexes vessel density of Optical Coherence Tomography Angiography
|
baseline and 4 days after carotid artery procedure
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Changes of Radical Peripapillary Capillaries Vessel Density
Ramy czasowe: 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
Ramy czasowe: baseline and 4 days after carotid artery procedure
|
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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Współpracownicy i badacze
Śledczy
- Główny śledczy: Hong Zhang, First Affiliated Hospital of Harbin Medical University
- Główny śledczy: Huaizhang Shi, First Affiliated Hospital of Harbin Medical University
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HZHZS1
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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