Retinal, Cerebral and Vascular Precursor Markers of Cerebral Small Vessel Disease.

NCT05305144 | Unknown

• 1 other identifier: CHUBX 2020/42
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive impairment and dementia are primarily due to a combination of vascular brain injury and neurodegenerative lesions. The vascular component is now recognized as a major contributor to the pathophysiology of dementia, with small vessel disease (SVD) being its most frequent substrate. This study aims to collect retinal microvascular markers as well as various parameters related to blood pressure and arterial stiffness, in a young adult population. The main objective is to explore the association between these parameters and structural changes on brain MRI. Results will allow to determine the most relevant biomarkers associated with very early brain imaging markers of SVD.

Conditions

Cerebral Small Vessel Diseases

Keywords

Cognitive decline; dementia; stroke; small vessel disease; brain imaging; adaptive optics; optical coherence tomography angiography; prevention; risk prediction

Outcome Measures

Primary Outcomes (1)

• Part 1 VASCULAR PARAMETERS RELATED TO BLOOD PRESSURE - Central arterial pressure by carotid tonometry (systolic, diastolic, mean)

  Central arterial pressure by carotid tonometry (systolic, diastolic, mean)

  within the inclusion visit (at the time of the vascular assessment)

Study Arms (1)

ophthalmological and vascular assessments

EXPERIMENTAL

This single-center national interventional study aims to collect ophthalmological (retinal image acquisition) and blood pressure (vascular assessment) data from 400 young adults from the Bordeaux bio-Share cohort, during two visits taking place one year apart.

Procedure: Vascular and ophthalmological examinations

Interventions

Vascular and ophthalmological examinations PROCEDURE

Part. 1 - Vascular checkup examinations: After collecting classic clinical parameters (weight, height, waist circumference), the in-depth vascular workup of each participant will include the following measurements: * Measurement of central arterial pressure, * Measurement of arterial stiffness, * Continuous blood pressure measurement (beat-to-beat), * Heart rate measurement, * 24-hour blood pressure measurement with QKD (holter). Part. 2 - Ophthalmological examinations: After dilating the pupil, a series of examinations will be conducted on the participant: * Auto-refractometry * Measurement of the axial length of the globe * Color retinophotography of the retina, * Adaptive Optics Exam * SS-OCT-A exam

ophthalmological and vascular assessments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• having signed the informed consent form of the MRi-Share sub-study,
• having signed the informed consent form for the bio-Share sub-study,
• for whom brain MRI images and for whom the results of the genome-wide genetic association study (GWAS) are of good quality
• being affiliated with social security.

You may not qualify if:

• participants with severe myopia greater than -6 dioptres
• participants with known allergy to Tropicamide (Mydriaticum®)

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• University of Bordeaux: collaborator

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Cerebral Small Vessel Diseases; Cognitive Dysfunction; Dementia; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Stéphanie DEBETTE, Pr

  INSERM U1219 Bordeaux Population Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: June 7, 2021
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

FR (1)