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临床试验/NCT06085612
NCT06085612招募中不适用

Impact of Significant Carotid Stenosis on Retinal Perfusion Measured Via Automated Retinal Oximetry

University Hospital Olomouc1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
Arterio-venous oxygen difference in retinal blood vessels measured by automated retinal oximetry.

研究概览

简要总结

Background: Large vessel carotid stenosis represent significant cause of ischaemic stroke. Indication for surgical revascularisation treatment relies on severity stenosis and clinical symptoms. Mild clinical symptoms such as transient ischemic attack, amaurosis fugax or minor stroke preceded large strokes in only 15% of cases.

Aim: The aim of this prospective study is to evaluate whether retinal perfusion is impacted in significant carotid stenosis. Automated retinal oximetry could be used to better evaluate perfusion in post-stenotic basin. The investigators presume the more stenotic blood vessel, the more reduced retinal perfusion is resulting in adaptive changes such as higher arteriovenous saturation difference due to greater oxygen extraction. This could help broaden the indication spectrum for revascularisation treatment for carotid stenosis.

Methods: The investigators plan to enroll 50 patients a year with significant carotid stenosis and cross-examine them with retinal oximetry. Study group will provide both stenotic vessels and non-stenotic vessels forming the control group. Patients with significant carotid stenosis will undergo an MRI examination to determine the presence of asymptomatic recent ischaemic lesions in the stenotic basin, and the correlation to oximetry parameters.

Statistics: Correlation between the severity of stenosis and retinal oximetry parameters will be compared to the control group of non-stenotic sides with threshold of 70%, respectively 80% and 90% stenosis. Data will be statistically evaluated at the 5% level of statistical significance. Results will be then reevaluated with emphasis on MRI findings in the carotid basin.

Conclusion: This prospective case control study protocol wil be used to launch a trial assessing the relationship between significant carotid stenosis and retinal perfusion measured via automated retinal oximetry.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Study population will include patients examined in ultrasound laboratory in Neurology department of University Hospital Olomouc, regardless of incidental finding of stenosis, examination due to acute symptoms or regular checkup of known stenosis.

排除标准

  • patients unable undergo ophthalmological examination properly, especially on automated retinal oximetry.

结局指标

主要结局

Arterio-venous oxygen difference in retinal blood vessels measured by automated retinal oximetry.

时间窗: 2028

To establish whether arterio-venous difference in the stenotic basin increases with the severity of stenosis and/or these changes vary depending on the severity of stenosis.

次要结局

  • Correlation with MRI ischaemic lesions(2029)

研究者

发起方
University Hospital Olomouc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michal Kral

Principal Investigator

University Hospital Olomouc

研究点 (1)

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