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Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04642586
Acronym
SOUCHY
Enrollment
40
Registered
2020-11-24
Start date
2021-01-07
Completion date
2024-01-05
Last updated
2023-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

MRI, Hypertension

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.

Interventions

Brain MRI exam (without contrast injection)

DIAGNOSTIC_TESTblood test

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

DIAGNOSTIC_TESTneuropsychological assessment

neuropsychological assessment

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
35 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Presence of a cerebral zone with a z-score > 1.96through study completion, an average of 1 yearthe 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

MeasureTime frameDescription
White matter hypersignalsthrough study completion, an average of 1 yearFAZEKAS score estimating T2 hypersignals of the white matter,
Microbleedsthrough study completion, an average of 1 yearnumber and location of microbleeds,
Gapsthrough study completion, an average of 1 yearnumber of gaps

Other

MeasureTime frameDescription
Correlation between MRI data and clinical scalesthrough study completion, an average of 1 yearMRI parameters will be correlated with clinical and neuropsychological using Spearman 'rank correlation.

Countries

France

Contacts

Primary ContactJean Darcourt, MD
darcourt.j@chu-toulouse.fr+33561775620
Backup ContactPatrice Péran, PHD
patrice.peran@inserm.fr05 62 74 61 96

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026