Retinal, Cerebral and Vascular Precursor Markers of Cerebral Small Vessel Disease. (SHIVA-SHARE)

October 5, 2023 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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®)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1 VASCULAR PARAMETERS RELATED TO BLOOD PRESSURE - Central arterial pressure by carotid tonometry (systolic, diastolic, mean)
Time Frame: within the inclusion visit (at the time of the vascular assessment)
Central arterial pressure by carotid tonometry (systolic, diastolic, mean)
within the inclusion visit (at the time of the vascular assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

University of Bordeaux

Investigators

  • Principal Investigator: Stéphanie DEBETTE, Pr, INSERM U1219 Bordeaux Population Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2021

Primary Completion (Estimated)

June 7, 2024

Study Completion (Estimated)

June 7, 2024

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

March 30, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2020/42

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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