Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI

NCT ID: NCT04642586

Last Updated: 2023-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-07

Study Completion Date

2024-01-05

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.

Conditions

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Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Hypertensive participants

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

Group Type EXPERIMENTAL

multimodal magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

Brain MRI exam (without contrast injection)

blood test

Intervention Type DIAGNOSTIC_TEST

Blood test to evaluate cardiovascular risk factors (cholesterol, triglycerides, LDL and HDL-CT, serum creatinine, fasting glucose, serum potassium), .

neuropsychological assessment

Intervention Type DIAGNOSTIC_TEST

neuropsychological assessment

Normotensive participants

absence of HTA confirmed by Ambulatory Blood Pressure Measure

Group Type EXPERIMENTAL

multimodal magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

Brain MRI exam (without contrast injection)

blood test

Intervention Type DIAGNOSTIC_TEST

Blood test to evaluate cardiovascular risk factors (cholesterol, triglycerides, LDL and HDL-CT, serum creatinine, fasting glucose, serum potassium), .

neuropsychological assessment

Intervention Type DIAGNOSTIC_TEST

neuropsychological assessment

Interventions

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multimodal magnetic resonance imaging

Brain MRI exam (without contrast injection)

Intervention Type DIAGNOSTIC_TEST

blood test

Blood test to evaluate cardiovascular risk factors (cholesterol, triglycerides, LDL and HDL-CT, serum creatinine, fasting glucose, serum potassium), .

Intervention Type DIAGNOSTIC_TEST

neuropsychological assessment

neuropsychological assessment

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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MRI

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Darcourt, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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CHU de Toulouse

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean Darcourt, MD

Role: CONTACT

+33561775620 ext. 33

Patrice Péran, PHD

Role: CONTACT

05 62 74 61 96 ext. 33

Other Identifiers

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RC31/19/0055

Identifier Type: -

Identifier Source: org_study_id

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