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Clinical Trials/NCT04712747
NCT04712747
Completed
Not Applicable

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

Fondation Ophtalmologique Adolphe de Rothschild1 site in 1 country91 target enrollmentJanuary 25, 2021
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Enrollment
91
Locations
1
Primary Endpoint
Wall cross-sectional area (WCSA) in adaptive optics
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 25, 2021
End Date
January 14, 2025
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Wall cross-sectional area (WCSA) in adaptive optics

Time Frame: 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

Time Frame: 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

Time Frame: 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

Study Sites (1)

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