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Clinical Trials/NCT05305144
NCT05305144
Active, not recruiting
Not Applicable

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

University Hospital, Bordeaux1 site in 1 country206 target enrollmentJune 7, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Small Vessel Diseases
Sponsor
University Hospital, Bordeaux
Enrollment
206
Locations
1
Primary Endpoint
Part 1 VASCULAR PARAMETERS RELATED TO BLOOD PRESSURE - Central arterial pressure by carotid tonometry (systolic, diastolic, mean)
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 7, 2021
End Date
June 7, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

Eligibility Criteria

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®)

Outcomes

Primary Outcomes

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)

Study Sites (1)

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