- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04326842
Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Heilongjiang
-
Harbin, Heilongjiang, Cina
- The First Affiliated Hospital of Harbin Medical University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Carotid artery stenosis
Patients with carotid artery stenosis.
Procedure: Carotid artery revascularization procedure
|
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.
|
|
Control
Patients without carotid artery stenosis
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Radical Peripapillary Capillaries Vessel Density
Lasso di tempo: Difference of vessel density in each group at baseline
|
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
Lasso di tempo: Difference of vessel density in each group at baseline
|
superficial vascular complexes vessel density of Optical Coherence Tomography Angiography
|
Difference of vessel density in each group at baseline
|
|
Deep Vascular Complexes Vessel Density
Lasso di tempo: 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
Lasso di tempo: Difference of vessel density in each group at baseline
|
choriocapillaris vessel density of Optical Coherence Tomography Angiography
|
Difference of vessel density in each group at baseline
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change of Difference of Mean Transit Time(dMTT)
Lasso di tempo: 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
|
|
Change of the Ratio of Cerebral Blood Flow(rCBF)
Lasso di tempo: baseline and 4 days after carotid artery procedure
|
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
Lasso di tempo: baseline and 4 days after carotid artery procedure
|
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
Lasso di tempo: 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
|
|
Changes of Radical Peripapillary Capillaries Vessel Density
Lasso di tempo: baseline and 4 days after carotid artery procedure
|
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
Lasso di tempo: baseline and 4 days after carotid artery procedure
|
changes of superficial vascular complexes vessel density of Optical Coherence Tomography Angiography
|
baseline and 4 days after carotid artery procedure
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Hong Zhang, First Affiliated Hospital of Harbin Medical University
- Investigatore principale: Huaizhang Shi, First Affiliated Hospital of Harbin Medical University
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HZHZS1
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .