Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 5, 2022

Detailed Description

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.

Interventions

  • Diagnostic Test: multimodal magnetic resonance imaging
    • Brain MRI exam (without contrast injection)
  • Diagnostic Test: blood test
    • Blood test to evaluate cardiovascular risk factors (cholesterol, triglycerides, LDL and HDL-CT, serum creatinine, fasting glucose, serum potassium), .
  • Diagnostic Test: neuropsychological assessment
    • neuropsychological assessment

Arms, Groups and Cohorts

  • Experimental: Hypertensive participants
    • diagnosed HTA within 5 years, treated or confirmed by Ambulatory Blood Pressure Measure;
  • Experimental: Normotensive participants
    • absence of HTA confirmed by Ambulatory Blood Pressure Measure

Clinical Trial Outcome Measures

Primary Measures

  • Presence of a cerebral zone with a z-score > 1.96
    • Time Frame: through study completion, an average of 1 year
    • 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).

Secondary Measures

  • White matter hypersignals
    • Time Frame: through study completion, an average of 1 year
    • FAZEKAS score estimating T2 hypersignals of the white matter,
  • Microbleeds
    • Time Frame: through study completion, an average of 1 year
    • number and location of microbleeds,
  • Gaps
    • Time Frame: through study completion, an average of 1 year
    • number of gaps

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Toulouse
  • Collaborator
    • Institut National de la Santé Et de la Recherche Médicale, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean Darcourt, MD, Principal Investigator, CHU toulouse
  • Overall Contact(s)
    • Jean Darcourt, MD, +33561775620, darcourt.j@chu-toulouse.fr

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