跳至主要内容
临床试验/NCT03291340
NCT03291340已完成不适用

A Pilot Cross-sectional Cohort Study of Right-to-left-shunt, Cerebrovascular Reactivity, Ischemic Infarct Burden on High Resolution MRI, and Cognitive Impairment in Elderly Subjects

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2017年10月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Presence of right-to-left shunt on TCD

研究概览

简要总结

The purpose of this study is to use transcanial doppler (TCD) ultrasound to look for possible risk factors for ischemic brain injury. We will perform contrast TCD with agitated saline contrast to identify and contrast right-to-left shunt (RLS) and breath holding to assess cerebrovascular reactivity (CVR) in the elderly.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females ≥ 60 years of age.
  • Fluent in English.
  • Part of the NACC longitudinal cohort (Protocol #: 068200) of the PMC/ADCC with consensus conference designation of cognitively normal, Mild Cognitive Impairment, or probable/possible Alzheimer's disease.
  • Has consented to participate in the ADCC high-resolution MRI sub-study.
  • NACC longitudinal visit must be within 6 months of the TCD study and brain MRI study.
  • Women: post-menopausal or surgically sterile.
  • Willing and able to complete all required study procedures.
  • Completed 6 grades of education.
  • Geriatric Depression scale less than 6 (assessed within 6 months at the NACC longitudinal visit).

排除标准

  • Prior clinically symptomatic ischemic or hemorrhagic stroke.
  • Inability to tolerate or contraindication to TCD study in the opinion of an investigator or treating physician.
  • Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

结局指标

主要结局

Presence of right-to-left shunt on TCD

时间窗: Baseline

Presence of cerebrovascular reactivity on TCD

时间窗: Baseline

次要结局

  • Volume of ischemic injury(Baseline)
  • Location of ischemic injury(Baseline)
  • Presence of cognitive impairment(Baseline)
  • Type of cognitive impairment(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven Messe

Associate Professor of Neurology

University of Pennsylvania

研究点 (1)

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