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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03986957
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
IRCCS Multimedica
Information provided by (Responsible Party):
Giuseppe Lembo, Neuromed IRCCS

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.

Condition or disease Intervention/treatment
Hypertension Other: No interventions

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Study Type : Observational
Estimated Enrollment : 176 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Novel Approaches of Advanced Neuroimaging Based on MRI Fiber Tracking to Detect Early Signs of Vascular Cognitive Impairment in Hypertensive Patients
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Group/Cohort Intervention/treatment
Hypertensive patients
Patients with SBP: 140-159; DBP: 90-99
Other: No interventions
No interventions - observational study

Primary Outcome Measures :
  1. Measurement of percentage change in diffusion parameters of the white matter [ Time Frame: At Enrollment; at 1 year Follow-up ]
    Fiber tracking by DTI MRI

Secondary Outcome Measures :
  1. Detection of cognitive decline by decrease of MoCA score [ Time Frame: At Enrollment; at 1 year Follow-up ]
    Cognitive tests

  2. Characterization of cardiac hypertensive organ damage progression [ Time Frame: At Enrollment; at 1 year Follow-up ]

  3. Characterization of renal hypertensive organ damage progression [ Time Frame: At Enrollment; at 1 year Follow-up ]

  4. Characterization of Blood Pressure Variability [ Time Frame: At Enrollment; at 1 year Follow-up ]
    24h registration of systolic and diastolic blood pressure

Biospecimen Retention:   Samples Without DNA
Blood and urine for biochemical analysis

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
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Responsible Party: Giuseppe Lembo, Full Professor, MD, PhD, Neuromed IRCCS Identifier: NCT03986957    
Other Study ID Numbers: LMB07
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giuseppe Lembo, Neuromed IRCCS:
Vascular Cognitive Impairment
Magnetic Resonance Imaging
Blood Pressure Variability
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders