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Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI (SOUCHY)

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
multimodal magnetic resonance imaging
blood test
neuropsychological assessment
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertension focused on measuring MRI, Hypertension

Eligibility Criteria

35 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CHU de ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hypertensive participants

Normotensive participants

Arm Description

diagnosed HTA within 5 years, treated or confirmed by Ambulatory Blood Pressure Measure;

absence of HTA confirmed by Ambulatory Blood Pressure Measure

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

White matter hypersignals
FAZEKAS score estimating T2 hypersignals of the white matter,
Microbleeds
number and location of microbleeds,
Gaps
number of gaps

Full Information

First Posted
November 6, 2020
Last Updated
March 13, 2023
Sponsor
University Hospital, Toulouse
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT04642586
Brief Title
Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI
Acronym
SOUCHY
Official Title
Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI (SOUCHY) Brain Changes Due to Hypertension: a Multimodal MRI
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2021 (Actual)
Primary Completion Date
December 5, 2023 (Anticipated)
Study Completion Date
January 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
MRI, Hypertension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypertensive participants
Arm Type
Experimental
Arm Description
diagnosed HTA within 5 years, treated or confirmed by Ambulatory Blood Pressure Measure;
Arm Title
Normotensive participants
Arm Type
Experimental
Arm Description
absence of HTA confirmed by Ambulatory Blood Pressure Measure
Intervention Type
Diagnostic Test
Intervention Name(s)
multimodal magnetic resonance imaging
Other Intervention Name(s)
MRI
Intervention Description
Brain MRI exam (without contrast injection)
Intervention Type
Diagnostic Test
Intervention Name(s)
blood test
Intervention Description
Blood test to evaluate cardiovascular risk factors (cholesterol, triglycerides, LDL and HDL-CT, serum creatinine, fasting glucose, serum potassium), .
Intervention Type
Diagnostic Test
Intervention Name(s)
neuropsychological assessment
Intervention Description
neuropsychological assessment
Primary Outcome Measure Information:
Title
Presence of a cerebral zone with a z-score > 1.96
Description
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).
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
White matter hypersignals
Description
FAZEKAS score estimating T2 hypersignals of the white matter,
Time Frame
through study completion, an average of 1 year
Title
Microbleeds
Description
number and location of microbleeds,
Time Frame
through study completion, an average of 1 year
Title
Gaps
Description
number of gaps
Time Frame
through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Correlation between MRI data and clinical scales
Description
MRI parameters will be correlated with clinical and neuropsychological using Spearman 'rank correlation.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Darcourt, MD
Phone
+33561775620
Ext
33
Email
darcourt.j@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Patrice Péran, PHD
Phone
05 62 74 61 96
Ext
33
Email
patrice.peran@inserm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Darcourt, MD
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Darcourt, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI

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