Retina Microvascular Remodeling and Cognitive Function In Hypertension

• Conditions: Hypertension; Mild Cognitive Impairment
• Interventions: Behavioral: Cognitive tests; Biological: Blood test; Radiation: Brain and aorta RMI; Other: Adaptative optics

• Registration Number: NCT02701855
• Lead Sponsor: Institute of Cardiometabolism and Nutrition, France

Brief 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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-08-04
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-02
• Last Update Submitted: 2016-03-02
• Study First Posted: 2016-03-08
• Last Update Posted: 2016-03-08
• Primary Completion: 2017-09
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypertension and progressive MCI	Cognitive tests	50 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics.
Hypertension and progressive MCI	Brain and aorta RMI	50 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics.
Hypertension and stable MCI	Cognitive tests	50 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics.
Hypertension and progressive MCI	Blood test	50 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics.
Hypertension, without MCI	Blood test	60 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics.
Hypertension and stable MCI	Blood test	50 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics.
Hypertension, without MCI	Cognitive tests	60 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics.
Hypertension, without MCI	Brain and aorta RMI	60 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics.
Hypertension and progressive MCI	Adaptative optics	50 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics.
Hypertension and stable MCI	Adaptative optics	50 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics.
Hypertension and stable MCI	Brain and aorta RMI	50 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics.
Hypertension, without MCI	Adaptative optics	60 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics.

Primary Outcome Measures

Name	Time	Method
Relationships between retina micro-vascular remodeling and cognitive function in hypertensive patients.	September 2017

Secondary Outcome Measures

Name	Time	Method
• Associations between retina arteriolar remodelling and proximal aortic stiffness indices.	September 2017
• Associations between cognitive function and proximal aortic stiffness indices estimated from MRI images.	September 2017
• Associations between retina arteriolar remodelling and cerebrovascular lesions (infarcts, lacuna, and white matter lesions) quantified from MRI images.	September 2017
• Associations between proximal aortic stiffness and cerebrovascular lesions (infarcts, lacuna, and white matter lesions) quantified from MRI images.	September 2017
• Associations between retina arteriolar remodelling and neurodegenerative lesions (hippocampus atrophy) quantified from MRI images.	September 2017
• Associations between proximal aortic stiffness and neurodegenerative lesions (hippocampus atrophy) quantified from MRI images.	September 2017

Trial Locations

Locations (1)

Unité de prévention des maladies cardiovasculaires Pôle Cardiologie/Métabolisme Hôpital Pitié-Salpétriêre, APHP, 83 bd de l'hôpital,; 🇫🇷 Paris, France