Novel Approaches of Advanced Neuroimaging Based on MRI Fiber Tracking to Detect Early Signs of Vascular Cognitive Impairment in Hypertensive Patients

Study Overview
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Brief Summary
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Hypertension is the major risk factor for vascular cognitive impairment (VCI). One of the main limitations in the clinical approach to VCI is that, by the time that it is manifested, it might be too late to reverse the neurodegenerative process. Thus, early identification of predictive signs of later dementia is demanding for management of hypertensive patients (HT).This aim claims for new methods that compute in a cloud all possible data sources coming from patients (brain imaging, cognitive profile, clinical data), to extract discriminative aggregate biomarkers. Thus, this study aims at: 1) characterizing the predictive potential of an aggregate biomarker for dementia in HT, based on brain imaging, clinical and cognitive assessment; 2) evaluating the impact of blood pressure variability, besides systolic/diastolic blood pressure, on the progression of the aggregate biomarker; 3) assessing whether specific classes of antihypertensive drugs differently affect the progression of the aggregate biomarker. In order to do this, this study proposes to evaluate advanced brain imaging and cognitive profile in a cohort of hypertensive patients, at baseline and after a 1 year follow up, to identify an innovative signature for the development of cognitive dysfunction in hypertension. In particular, the effects of blood pressure variability and of different classes of antihypertensive drugs will be evaluated.

Official Title
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Novel Approaches of Advanced Neuroimaging Based on MRI Fiber Tracking to Detect Early Signs of Vascular Cognitive Impairment in Hypertensive Patients

Conditions
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Hypertension

Intervention / Treatment
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* Other: No interventions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 40 and ≤ 70 years patients with moderate hypertension written informed consent Exclusion Criteria: previous IMA, stroke or TIA arrhythmia or severe cardiac disease Diabetes or renal disease psychiatric disease neurological or neurodegenerative disease dementia assumption of drugs known to interfere with cognitive function inability to be subjected MRI analysis participation to other clinical trial, ongoing or terminated less than one month before enrolment in this study.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypertensive patients<br>Patients with SBP: 140-159; DBP: 90-99 | Other: No interventions<br>* No interventions - observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of percentage change in diffusion parameters of the white matter | Fiber tracking by DTI MRI | At Enrollment; at 1 year Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of cognitive decline by decrease of MoCA score | Cognitive tests | At Enrollment; at 1 year Follow-up | 
| Characterization of cardiac hypertensive organ damage progression | Echography | At Enrollment; at 1 year Follow-up | 
| Characterization of renal hypertensive organ damage progression | eGFR | At Enrollment; at 1 year Follow-up | 
| Characterization of Blood Pressure Variability | 24h registration of systolic and diastolic blood pressure | At Enrollment; at 1 year Follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular Cognitive Impairment, Magnetic Resonance Imaging, Blood Pressure Variability