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临床试验/NCT04712747
NCT04712747已完成不适用

Adaptive Optics (AO) Analysis of Retinal Arteries in Patients With Recent Stroke (STROKAO)

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2021年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
1
主要终点
Wall cross-sectional area (WCSA) in adaptive optics

研究概览

简要总结

The eye has long been recognized as a window to pathological processes occurring in the brain. By imaging the vascular system of the retina scientific understanding and clinical practice have been improved for a wide range of pathologies from diabetes to stroke and dementia.

Adaptive optics (AO) reveals retinal details that remain invisible with other current imaging techniques. Indeed, vessels can be perfectly visualized, making it possible to detect wall irregularities, accurately measure their different structures and monitor their evolution under treatment if necessary.

In AO, studies on retinal vessels involve the calculation of wall thickness (WT), outer diameter (OD), inner diameter (ID), wall cross-sectional area (WCSA) and wall to lumen ratio (WLR). An increase in WLR > 0.31 is characteristic of hypertensive microangiopathy and predictive of cardiovascular and brain damage. This accurate assessment of microvascular structure may even be required in the near future in all patients with arterial hypertension. For vessels > 300 microns in diameter, the increase in vessel wall thickness occurs without changing the ID, a process known as external hypertrophic remodeling. For small arteries < 300 microns, remodeling occurs differently. The total volume of the vessel wall remains constant, but the OD and ID each decrease, a process known as inward eutrophic remodeling.

The objective of this study is to describe the parameters measured in AO in patients in the acute phase of a stroke and then at 3 months.

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

  • For the patients with stroke: Inpatients with confirmed stroke (clinical and imaging) for less than 10 days
  • For the controls: Individuals presenting at the Rothschild Foundation Hospital with no history of stroke who are matched to cases already included in the matching criteria: Age ± 5 years, Gender, high blood pressure (no history, untreated, treated) Diabetes (Yes, No), Body Mass Index (BMI < 25, 25 ≥ BMI < 30, BMI ≥ 30)

排除标准

  • Pregnant or breastfeeding woman
  • Insufficient state of consciousness or physical condition to perform the adaptive optics examination
  • For the patients with stroke: Hemorrhagic post-traumatic hematoma stroke type, or symptomatic stroke of a brain tumour or an arteriovenous malformation.

结局指标

主要结局

Wall cross-sectional area (WCSA) in adaptive optics

时间窗: At the inclusion visit (less than 10 days after the stroke for the patients with stroke)

Measured in µm², Comparison between groups : hemorrhagic strokes, ischemic strokes, controls

Wall to lumen ratio (WLR) in adaptive optics

时间窗: At the inclusion visit (less than 10 days after the stroke for the patients with stroke)

Comparison between groups : hemorrhagic strokes, ischemic strokes, controls

Wall thickness (WT) in adaptive optics

时间窗: At the inclusion visit (less than 10 days after the stroke for the patients with stroke)

Measured in µm², Comparison between groups : hemorrhagic strokes, ischemic strokes, controls

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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