An observational study in Hypertension and Mild Cognitive Impairment, sponsored by Institute of Cardiometabolism and Nutrition, France. Status unknown at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2016-03-08.
Sponsored by Institute of Cardiometabolism and Nutrition, France · Observational
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).
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:
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 160 is below the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →Institute of Cardiometabolism and Nutrition, France is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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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:
Exclusion Criteria:
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
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
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
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)
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
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.
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.
Relationships between retina micro-vascular remodeling and cognitive function in hypertensive patients.
Time frame: September 2017
• Associations between cognitive function and proximal aortic stiffness indices estimated from MRI images.
Time frame: September 2017
• Associations between retina arteriolar remodelling and cerebrovascular lesions (infarcts, lacuna, and white matter lesions) quantified from MRI images.
Time frame: September 2017
• Associations between retina arteriolar remodelling and neurodegenerative lesions (hippocampus atrophy) quantified from MRI images.
Time frame: September 2017
• Associations between proximal aortic stiffness and cerebrovascular lesions (infarcts, lacuna, and white matter lesions) quantified from MRI images.
Time frame: September 2017
• Associations between proximal aortic stiffness and neurodegenerative lesions (hippocampus atrophy) quantified from MRI images.
Time frame: September 2017
• Associations between retina arteriolar remodelling and proximal aortic stiffness indices.
Time frame: September 2017
This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Institute of Cardiometabolism and Nutrition, France