Retinal, Cerebral and Vascular Precursor Markers of Cerebral Small Vessel Disease. (SHIVA-SHARE)
Primary Purpose
Cerebral Small Vessel Diseases
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vascular and ophthalmological examinations
Sponsored by
About this trial
This is an interventional prevention trial for Cerebral Small Vessel Diseases focused on measuring Cognitive decline, dementia, stroke, small vessel disease, brain imaging, adaptive optics, optical coherence tomography angiography, prevention, risk prediction
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®)
Sites / Locations
- CHU de Bordeaux
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ophthalmological and vascular assessments
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05305144
First Posted
March 22, 2022
Last Updated
October 5, 2023
Sponsor
University Hospital, Bordeaux
Collaborators
University of Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT05305144
Brief Title
Retinal, Cerebral and Vascular Precursor Markers of Cerebral Small Vessel Disease.
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
June 7, 2024 (Anticipated)
Study Completion Date
June 7, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
University of Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Small Vessel Diseases
Keywords
Cognitive decline, dementia, stroke, small vessel disease, brain imaging, adaptive optics, optical coherence tomography angiography, prevention, risk prediction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ophthalmological and vascular assessments
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Vascular and ophthalmological examinations
Intervention Description
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
Primary Outcome Measure Information:
Title
Part 1 VASCULAR PARAMETERS RELATED TO BLOOD PRESSURE - Central arterial pressure by carotid tonometry (systolic, diastolic, mean)
Description
Central arterial pressure by carotid tonometry (systolic, diastolic, mean)
Time Frame
within the inclusion visit (at the time of the vascular assessment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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®)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphanie DEBETTE, Pr
Organizational Affiliation
INSERM U1219 Bordeaux Population Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
12. IPD Sharing Statement
Learn more about this trial
Retinal, Cerebral and Vascular Precursor Markers of Cerebral Small Vessel Disease.
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