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

Neuromed IRCCS

Status

Unknown

Conditions

Hypertension

Treatments

Other: No interventions

Study type

Observational

Funder types

Other

Identifiers

NCT03986957

LMB07

Details and patient eligibility

About

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.

Enrollment

176 estimated patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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.