Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI

Study Overview
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Brief Summary
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Investigators propose here to study the brain consequences of hypertension in patients without cognitive complaints and neurological signs. The evaluation of brain suffering requires considering various possible brain damage. The team developed a multimodal MRI approach capable of detecting and quantifying numerous indices (e.g. morphometric, microstructural) to evaluate possible brain suffering. This project aims to identify individually signs of cerebral suffering in hypertensive patients compared to a population of normotensive volunteers, using advanced multiparametric MRI methods.

Detailed Description
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Hypertension is a risk factor for many brain pathologies, such as ischemic and hemorrhagic neurodegenerative diseases or stroke. The literature seems to agree on the relationship between hypertension and brain damage, and on the benefit of the management of hypertension to prevent certain neurological pathologies. However, to our knowledge, no single study has shown signs of subclinical brain damage in patients with hypertension. At present, no brain MRI is recommended in these patients. In the present study, hypertensive and normotensive patients will undergo a neurological exam, a neuropsychological exam, a biological exam and a MRI exam to individually identify signs of cerebral suffering.

Official Title
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Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI (SOUCHY) Brain Changes Due to Hypertension: a Multimodal MRI

Conditions
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Hypertension

Intervention / Treatment
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* Diagnostic Test: multimodal magnetic resonance imaging
* Diagnostic Test: blood test
* Diagnostic Test: neuropsychological assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female 35 to 50 y.o.;for patients: diagnosed HTA within 5 years, treated or confirmed by Ambulatory Blood Pressure Measure; For normotensive participants:Absence of HTA confirmed by Ambulatory Blood Pressure Measure Exclusion Criteria: Known neurological history, stroke, symptomatic headache, long-term use of neuroleptic, tricyclic, MAOI, anti-serotonergic antidepressant medications, diabetes mellitus, treated dyslipidemia, body mass index greater than 30 kg / m, participants who smoked or smoked more than 10 packs-year, MRI contraindication ; For HTA patients only: Renal artery dysplasia responsible for hypertension, clinical Cushing Syndrome.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypertensive participants<br>diagnosed HTA within 5 years, treated or confirmed by Ambulatory Blood Pressure Measure; | Diagnostic Test: multimodal magnetic resonance imaging<br>* Brain MRI exam (without contrast injection)<br>* Other names: MRI;Diagnostic Test: blood test<br>* Blood test to evaluate cardiovascular risk factors (cholesterol, triglycerides, LDL and HDL-CT, serum creatinine, fasting glucose, serum potassium), .<br>Diagnostic Test: neuropsychological assessment<br>* neuropsychological assessment<br>|
| Experimental: Normotensive participants<br>absence of HTA confirmed by Ambulatory Blood Pressure Measure | Diagnostic Test: multimodal magnetic resonance imaging<br>* Brain MRI exam (without contrast injection)<br>* Other names: MRI;Diagnostic Test: blood test<br>* Blood test to evaluate cardiovascular risk factors (cholesterol, triglycerides, LDL and HDL-CT, serum creatinine, fasting glucose, serum potassium), .<br>Diagnostic Test: neuropsychological assessment<br>* neuropsychological assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of a cerebral zone with a z-score > 1.96 | the proportion of hypertensive patients who have at least one sign of cerebral suffering compared to the control group will be determined. For each MRI parameter, after coregistration, z score maps will be calculated for each hypertensive patient (individual vs normotensive group). The notion of cerebral suffering sign will be defined by the presence of a cerebral zone with a z-score greater than 1.96 (corresponding to a threshold of significance p <.05). | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White matter hypersignals | FAZEKAS score estimating T2 hypersignals of the white matter, | through study completion, an average of 1 year | 
| Microbleeds | number and location of microbleeds, | through study completion, an average of 1 year | 
| Gaps | number of gaps | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Hypertension