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

Cerebral Small Vessel Diseases Clinical Trial

— SHIVA-SHARE  

Official title:

Identification and Evaluation of Micro-vascular Retinal and Brain Markers to Establish Potential Early Brain Structural Alterations in Young Adults - SHIVA-Share

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05305144
• Other study ID #: CHUBX 2020/42
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: June 7, 2024

Study information

• Verified date: October 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 206
• Est. completion date: June 7, 2024
• Est. primary completion date: June 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Young adults from the i-Share cohort will be included in the study:

• 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: Will not be included in the study:

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

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	University of Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)