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

NCT ID: NCT05305144

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-07
• Study Completion Date: 2024-06-07

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.

Detailed Description

Small Vessel Disease is most often covert i.e detectable only on brain images without being associated with a clinical stroke. Covert SVD (cSVD) is highly prevalent in older persons from the general population and is a powerful predictor of future cognitive decline and dementia risk. Better detection of covert cSVD, particularly at the earliest stages, would have a major impact on preventing disability and costs related to stroke, cognitive impairment and dementia. Studying the association of retinal and vascular biomarkers with MRI markers of brain structure will enable to facilitate the detection of patients at high risk of developing cSVD and its complications. This study aims to collect ophthalmological (retinal image acquisition - Part 1 of the study) and blood pressure / arterial stiffness (vascular assessment - Part 2 of the study) markers from 400 young adults from the Bordeaux bio-Share study. In Part 1, microvascular retinal biomarkers will be revealed by two complementary advanced technologies: the Swept-source optical coherence tomography angiography (SS-OCT-A) and the Adaptative Optics (AO). In Part 2, participants will benefit from an in-depth vascular assessment.

Conditions

Cerebral Small Vessel Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ophthalmological and vascular assessments

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.

Group Type: EXPERIMENTAL

Vascular and ophthalmological examinations

Intervention Type: 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

Interventions

Vascular and ophthalmological examinations

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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
• having signed freely, an informed and written consent for this study (at the latest on the day of inclusion and before any examination required by the research),
• being affiliated with social security.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bordeaux

OTHER

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphanie DEBETTE, Pr

Role: PRINCIPAL_INVESTIGATOR

INSERM U1219 Bordeaux Population Health

Locations

CHU de Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2020/42

Identifier Type: -

Identifier Source: org_study_id