Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI

Hypertension Clinical Trial

— SOUCHY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04642586
• Other study ID #: RC31/19/0055
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2021
• Est. completion date: January 5, 2024

Study information

• Verified date: March 2023
• Source: University Hospital, Toulouse
• Contact: Jean Darcourt, MD
• Phone: +33561775620
• Email: darcourt.j[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 5, 2024
• Est. primary completion date: December 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
France	CHU de Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between MRI data and clinical scales	MRI parameters will be correlated with clinical and neuropsychological using Spearman 'rank correlation.	through study completion, an average of 1 year
Primary	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	White matter hypersignals	FAZEKAS score estimating T2 hypersignals of the white matter,	through study completion, an average of 1 year
Secondary	Microbleeds	number and location of microbleeds,	through study completion, an average of 1 year
Secondary	Gaps	number of gaps	through study completion, an average of 1 year