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

NCT03986957 | Unknown

• 1 other identifier: LMB07
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Vascular Cognitive Impairment; Magnetic Resonance Imaging; Blood Pressure Variability

Outcome Measures

Primary Outcomes (1)

• Measurement of percentage change in diffusion parameters of the white matter

  Fiber tracking by DTI MRI

  At Enrollment; at 1 year Follow-up

Secondary Outcomes (4)

• Detection of cognitive decline by decrease of MoCA score

  At Enrollment; at 1 year Follow-up

• Characterization of cardiac hypertensive organ damage progression

  At Enrollment; at 1 year Follow-up

• Characterization of renal hypertensive organ damage progression

  At Enrollment; at 1 year Follow-up

• Characterization of Blood Pressure Variability

  At Enrollment; at 1 year Follow-up

Study Arms (1)

Hypertensive patients

Patients with SBP: 140-159; DBP: 90-99

Other: No interventions

Interventions

No interventions OTHER

No interventions - observational study

Hypertensive patients

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be selected from patients attending the Department of AngioCardioNeurology of the IRCCS Neuromed, accordingly to the following inclusion/exclusion criteria. Approximately 176 subjects of both genders will be included in the study.

You may qualify if:

• age ≥ 40 and ≤ 70 years
• patients with moderate hypertension
• written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuromed IRCCS: lead
• IRCCS Multimedica: collaborator

Study Sites (1)

IRCCS Neuromed

Pozzilli, Isernia, 86077, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine for biochemical analysis

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Giuseppe Lembo, MD, PhD

CONTACT

+390865915225; lembo@neuromed.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, MD, PhD

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 14, 2019
• Study Start: December 9, 2019
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: January 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)