Retina Microvascular Remodeling and Cognitive Function In Hypertension

NCT02701855 | Unknown

• 1 other identifier: 14DRM_EYEBRAIN
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypertension; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Relationships between retina micro-vascular remodeling and cognitive function in hypertensive patients.

  September 2017

Secondary Outcomes (6)

• • 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 retina arteriolar remodelling and neurodegenerative lesions (hippocampus atrophy) 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 proximal aortic stiffness and neurodegenerative lesions (hippocampus atrophy) quantified from MRI images.

  September 2017

Study Arms (3)

Hypertension and progressive MCI

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

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

Hypertension and stable MCI

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

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

Hypertension, without MCI

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

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

Interventions

Cognitive tests BEHAVIORAL

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)

Hypertension and progressive MCI; Hypertension and stable MCI; Hypertension, without MCI

Blood test BIOLOGICAL

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

Hypertension and progressive MCI; Hypertension and stable MCI; Hypertension, without MCI

Brain and aorta RMI RADIATION

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.

Hypertension and progressive MCI; Hypertension and stable MCI; Hypertension, without MCI

Adaptative optics OTHER

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.

Hypertension and progressive MCI; Hypertension and stable MCI; Hypertension, without MCI

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients' recruitment will be carried out in two centers to ensure inclusion of both patients: 1) with hypertension and without cognitive impairment, 2) with hypertension and with mild cognitive impairment (without dementia) including patients with stable MCI and converters. Population size: 160 patients: * 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

You may qualify if:

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

You may not qualify if:

• Impossibility to visualize the retinal : severe cataract
• Dementia (defined by MMSE\<20)
• Clinical stroke
• Severe or resistant Hypertension
• Hypertension treated with more than 3 different pharmacological classes
• any other disease that may interfere with the assessment of cognitive disorders (epilepsy, Parkinson's disease, major depression, schizophrenia, manic-depressive)
• Enrolment in a therapeutic trial that could interfere with the main objective
• Less than 4 years of formal education
• Illiterate, unable to read, write or count
• major physical problems that may interfere with the tests (sight, hearing, ...)
• Short term life threatening disease
• Non-affiliation to a healthcare system
• Consent refusal
• 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

Sponsors & Collaborators

• Institute of Cardiometabolism and Nutrition, France: lead
• Fondation de Recherche sur l'Hypertension Artérielle: collaborator

Study Sites (1)

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

Paris, 75013, France

RECRUITING

Related Publications (14)

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• Redheuil A, Yu WC, Mousseaux E, Harouni AA, Kachenoura N, Wu CO, Bluemke D, Lima JA. Age-related changes in aortic arch geometry: relationship with proximal aortic function and left ventricular mass and remodeling. J Am Coll Cardiol. 2011 Sep 13;58(12):1262-70. doi: 10.1016/j.jacc.2011.06.012.

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• Rosenbaum D, Koch E, Girerd X, Rossant F, Paques M. [Imaging of retinal arteries with adaptative optics, feasibility and reproducibility]. Ann Cardiol Angeiol (Paris). 2013 Jun;62(3):184-8. doi: 10.1016/j.ancard.2013.04.017. Epub 2013 May 29. French.

  PMID: 23773704 BACKGROUND

• Herment A, Kachenoura N, Lefort M, Bensalah M, Dogui A, Frouin F, Mousseaux E, De Cesare A. Automated segmentation of the aorta from phase contrast MR images: validation against expert tracing in healthy volunteers and in patients with a dilated aorta. J Magn Reson Imaging. 2010 Apr;31(4):881-8. doi: 10.1002/jmri.22124.

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• Dogui A, Kachenoura N, Frouin F, Lefort M, De Cesare A, Mousseaux E, Herment A. Consistency of aortic distensibility and pulse wave velocity estimates with respect to the Bramwell-Hill theoretical model: a cardiovascular magnetic resonance study. J Cardiovasc Magn Reson. 2011 Jan 27;13(1):11. doi: 10.1186/1532-429X-13-11.

  PMID: 21272312 BACKGROUND

MeSH Terms

Conditions

Hypertension; Cognitive Dysfunction

Interventions

Neuropsychological Tests; Hematologic Tests

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

David Rosenbaum, Dr

CONTACT

01 42 17 57 74; david.rosenbaum@psl.aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: March 8, 2016
• Study Start: October 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

FR (1)