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临床试验/NCT03986957
NCT03986957Unknown不适用

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

Neuromed IRCCS1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2019年12月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
176
试验地点
1
主要终点
Measurement of percentage change in diffusion parameters of the white matter

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • previous IMA, stroke or TIA
  • arrhythmia or severe cardiac disease
  • Diabetes or renal disease
  • psychiatric disease
  • neurological or neurodegenerative disease
  • 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.

结局指标

主要结局

Measurement of percentage change in diffusion parameters of the white matter

时间窗: At Enrollment; at 1 year Follow-up

Fiber tracking by DTI MRI

次要结局

  • 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)

研究者

发起方
Neuromed IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe Lembo

Full Professor, MD, PhD

Neuromed IRCCS

研究点 (1)

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