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

Recruiting

• Conditions: Stroke
• Interventions: Procedure: Ophthalmological examinations; Procedure: Blood pressure measurement at rest

• Registration Number: NCT04712747
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-15
• Study Start: 2021-01-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16
• Primary Completion: 2025-01-25
• Study Completion: 2025-01-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases - patients with stroke	Blood pressure measurement at rest	Ophthalmological examinations : At the inclusion visit and 3 months after their stroke Blood pressure measurement at rest : At the inclusion visit
Cases - patients with stroke	Ophthalmological examinations	Ophthalmological examinations : At the inclusion visit and 3 months after their stroke Blood pressure measurement at rest : At the inclusion visit
Controls - Individuals with no history of stroke	Ophthalmological examinations	Ophthalmological examinations : At the inclusion visit Blood pressure measurement at rest : At the inclusion visit
Controls - Individuals with no history of stroke	Blood pressure measurement at rest	Ophthalmological examinations : At the inclusion visit Blood pressure measurement at rest : At the inclusion visit

Primary Outcome Measures

Name	Time	Method
Wall cross-sectional area (WCSA) in adaptive optics	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	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	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

Trial Locations

Locations (1)

Hôpital Fondation A. de Rothschuld; 🇫🇷 Paris, France