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临床试验/NCT00390481
NCT00390481已完成不适用

Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON)

Columbia University1 个研究点 分布在 1 个国家目标入组 294 人开始时间: 2004年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
294
试验地点
1
主要终点
Cognitive Functioning on Neuropsychological assessment measures

研究概览

简要总结

To determine the relationship between cognitive functioning and blood flow in the brain among patients randomized to either extracranial-intracranial (EC-IC) bypass or medical therapy alone in the Carotid Occlusion Surgery Study (COSS).

详细描述

The Carotid Occlusion Surgery Study (COSS) evaluates whether a surgical operation, EC-IC bypass surgery, can reduce the chance of a stroke in someone who has complete blockage in one main artery in the neck that supplies blood to the brain (the carotid artery). The operation bypasses the blockage so more blood can flow to the brain. Only people with decreased blood flow to the brain, as demonstrated on a PET (positron emission tomographic) scan, are randomized into the COSS study. Among patients randomized into the COSS study, RECON will evaluate whether restoring the blood flow to the brain (with EC-IC bypass surgery) will also improve mental functioning. Participants in both the surgical and medical groups of the COSS study will participate in the RECON study. By comparing the mental functioning of the participants in both treatment groups over the course of 2 years, the investigators hope to determine whether the EC-IC bypass operation also helps improve or maintain mental functioning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Enrollment into Carotid Occlusion Surgery Study

排除标准

  • Prior diagnosis of dementia

结局指标

主要结局

Cognitive Functioning on Neuropsychological assessment measures

时间窗: 2 years

次要结局

  • Quality of Life and Disability(2 years)

研究者

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

Randolph S. Marshall

Professor at Affil Hosp/Inst

Columbia University

研究点 (1)

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