Retinal, Cerebral & Vascular Precursor Markers of Cerebral Small Vessel

Status Active, not recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Cerebral Small Vessel Diseases

Clinical Trial Details

NCT number	NCT05305144
Study type	Interventional
Source	University Hospital, Bordeaux
Contact
Status	Active, not recruiting
Phase	N/A
Start date	June 7, 2021
Completion date	June 7, 2024

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms