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临床试验/NCT05292729
NCT05292729Unknown不适用

Cognitive Function and Brain Connectivity in Carotid Artery Stenting Patients:a Rs-fMRI Study

First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Montreal Cognitive Assessment, MOCA

研究概览

简要总结

This is a prospective study aimed to explore the changes of cognitive function after surgery for CAS and the correlation with brain connectivity, in order to look for the clinical biomarkers to predict the carotid stent implantation for patients which can effect the cognition

详细描述

Carotid artery stenting (CAS) can significantly decrease the incidence of ischemic stroke in patients with severe carotid artery stenosis has been confirmed in large randomized controlled studies (1, 2).Previous studies showed carotid artery stenosis is closely related to cognitive dysfunction, including asymptomatic carotid artery stenosis(≥70%).Cognitive impairment is one of the most serious problem facing the elderly. The impact on cognitive function in patients with CAS has been discussed by many researchers, however the effect still remained conflicting.

In past few years, several imaging techniques, such as resting-state functional MRI (R-fMRI), had been increasingly used to study cognitive impairment in humans. In this study, we evaluated the cognition performance in severe carotid artery stenosis patients undergoing CAS and explored the mechanisms underlying the cognition changes by the Rs-fMRI.

Inclusion criteria:

  • age between 55 years and 80 years
  • unilateral internal carotid artery stenotic degree ≥ 70%
  • right-hand-dominant
  • free of dementia, and depression
  • modified Rankin Scale: 0 or 1
  • education ≥6 years
  • obtained written informed consent.

Exclusion criteria:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 55 years and 80 years
  • unilateral internal carotid artery stenotic degree ≥ 70%
  • right-hand-dominant
  • free of stroke, TIA, dementia, and depression
  • modified Rankin Scale: 0 or 1
  • education ≥6 years
  • obtained written informed consent.

排除标准

  • contralateral internal carotid artery stenosis ≥ 50%
  • posterior circulation diseases
  • MMSE < 26, which is a cut-off value for mild cognitive impairment
  • severe systemic diseases and neuropsychiatric diseases (such as congestive heart failure and history of stroke)
  • any contraindications for MRI scan (e.g., metal implants)

结局指标

主要结局

Montreal Cognitive Assessment, MOCA

时间窗: 3 months after CAS

use MOCA to assess the cognition after CAS

Mini-mental State Examination,MMSE

时间窗: 3 months after CAS

use MMSE to assess the cognition after CAS

次要结局

  • Digit Symbol Test(3 months after CAS)
  • Trail Making Test A/B(3 months after CAS)
  • digital span test(3 months after CAS)

研究者

发起方
First Affiliated Hospital of Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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