NCT02701855

Retina Microvascular Remodeling and Cognitive Function In Hypertension

Retina Microvascular Remodeling and Cognitive Function In Hypertension : Eyebrain

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: Institute of Cardiometabolism and Nutrition, France · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to determine the relationships between retina micro-vascular remodeling and cognitive function in hypertensive patients. The study plans to enrol 160 patients (100 patients with mild cognitive impairment -MCI- and 60 without MCI).

Detailed description

Our project stands on physiopathological and cognitive angles, and is mainly based on the major role of large and small arteries elasticity on cognitive aging. It will benefit from the recent innovative accurate and non invasive techniques such as MRI for central large arteries and adaptative optics for retina arterioles imaging. Study population is the following: * 60 patients with hypertension and no MCI, * 50 patients with hypertension and stable MCI, without dementia * 50 patients with hypertension and progressive MCI, without dementia Every patients will perform a medical interview and examination, an MRI (brain + aorta), adaptative optics imaging, a cognitive tests and a blood test. Primary outcome is to determine the relationships between retina micro-vascular remodeling and cognitive function in this population.

Conditions

• Hypertension
• Mild Cognitive Impairment

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive tests	Cognitive tests include: * The MMSE (Mini Mental State Examination) * Free and Cued Selective Recall Reminding Test (FCSRT). * Executive functions (fluencies, TMT A and B, span). * Tests of verbal fluency (literal and category) * Digit symbol substitution test or Wechsler adult intelligence scale (W.A.I.S) * The Clinical Dementia Rating Scale * The IADL scale evaluates autonomy. * Geriatric Depression screening Scale (GDS)
BIOLOGICAL	Blood test	A blood test will be performed in order to collect following parameters: Urea, BUN, Creatinine, Potassium, Sodium, hematocrit, hsCRP, NFS, Pq, LDL-C, HDL-C, Triglycerides, Lp(a), Lp-PLA2 as well as fasting glucose, HbA1C and microalbuminuria
RADIATION	Brain and aorta RMI	A magnetic resonance imaging exam will be performed at the Neuroimaging Research Center of the Pitié-Salpêtrière Hospital. This exam will be optimized to fit in 30 minutes. Indeed brain 3D T1 and T2 FLAIR imaging lasts 15 minutes while cine and velocity encoded imaging of the aorta lasts 15 minutes.
OTHER	Adaptative optics	The retina adaptative optic imaging will be performed at the "Unité de prevention des maladies cardiovasculaires" Pitié Salpetrière Hospital. This exam lasts 10 minutes including patient positioning and imaging.

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-09-01
• Completion: 2017-12-01
• First posted: 2016-03-08
• Last updated: 2016-03-08

Locations

1 site across 1 country: France