Retina Microvascular Remodeling and Cognitive Function In Hypertension (EYEBRAIN)

Institute of Cardiometabolism and Nutrition, France

Status: Unknown

Conditions: Hypertension; Mild Cognitive Impairment

Treatments: Radiation: Brain and aorta RMI; Biological: Blood test; Other: Adaptative optics; Behavioral: Cognitive tests

Study type: Observational

Funder types: Other

Identifiers

NCT02701855

14DRM_EYEBRAIN

Details and patient eligibility

About

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).

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 65 or more
2. hypertension (BP ≥140/90 mmHg and/or antihypertensive treatment)
3. Signed informed consent by the patient
4. Sufficient mastery of the French language to perform neuropsychological tests

Exclusion criteria

1. Impossibility to visualize the retinal : severe cataract
2. Dementia (defined by MMSE<20)
3. Clinical stroke
4. Severe or resistant Hypertension
5. Hypertension treated with more than 3 different pharmacological classes
6. any other disease that may interfere with the assessment of cognitive disorders (epilepsy, Parkinson's disease, major depression, schizophrenia, manic-depressive)
7. Enrolment in a therapeutic trial that could interfere with the main objective
8. Less than 4 years of formal education
9. Illiterate, unable to read, write or count
10. major physical problems that may interfere with the tests (sight, hearing, ...)
11. Short term life threatening disease
12. Non-affiliation to a healthcare system
13. Consent refusal
14. Contraindication to MRI including claustrophobia, metallic devices, pacemaker, mechanical valve implanted before 1985, and nursing, as well as technical contra-indication: patient diameter > 70 cm or/and weight > 250 kg

Trial design

160 participants in 3 patient groups

Hypertension and progressive MCI

Description:

50 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics.

Treatment:

Radiation: Brain and aorta RMI

Biological: Blood test

Behavioral: Cognitive tests

Other: Adaptative optics

Hypertension and stable MCI

Description:

50 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics.

Treatment:

Radiation: Brain and aorta RMI

Biological: Blood test

Behavioral: Cognitive tests

Other: Adaptative optics

Hypertension, without MCI

Description:

60 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics.

Treatment:

Radiation: Brain and aorta RMI

Biological: Blood test

Behavioral: Cognitive tests

Other: Adaptative optics