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临床试验/NCT00597883
NCT00597883已完成不适用

Neurologic and Neuropsychometric Outcome in Patients Undergoing Carotid Endarterectomy

Columbia University1 个研究点 分布在 1 个国家目标入组 817 人开始时间: 2003年3月1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
817
试验地点
1
主要终点
Percentage of Patients Having a Significant Change in Neuropsychometric Performance After Carotid Endarterectomy

研究概览

简要总结

The purpose of this study is to determine how well patients undergoing carotid endarterectomy will perform on a battery of tests to assess brain function before and after surgery as compared to a control group of patients undergoing spine surgery. This study will serve to: (a) determine incidence of neurologic/neuropsychometric change in patients undergoing carotid artery surgery, and (b) to ascertain the time it takes for these changes to resolve.

详细描述

Cerebral injury will be determined in four ways. First, all patients will be evaluated using a battery of neuropsychometric tests before and after surgery. Patients admitted to the Irving Clinical Research Center (CRC) will have their tests one day before, one day after surgery and at 1 month. Those coming into the hospital on the day of surgery, "Same Day", will be evaluated on the day of surgery, one day after and at the 1 month follow up. Preoperative neurological and neuropsychological evaluation will be performed. The neuropsychometric tests are not intended to be diagnostic of specific neuropsychiatric disorders, but rather are designed to demonstrate general neuropsychological pathology. These tests can be divided into four types: (1) an evaluation of language, (2) an evaluation of speed of mental processing, (3) an evaluation of ability to learn using a list of words, and (4) an evaluation of visual perception requiring a patient to copy a complex figure. Before the battery is administered we will assess each patient's level of pain while sitting and standing using a 10 point Visual Analog Scale and then gauge their mood with a series called the Wong/Baker Faces Rating scale.

We will be measuring Quality of Life (QOL) in all enrolled patients. This will be done using two well-known examinations (Telephone Interview for Cognitive Status (TICS) and Centers for Disease Control and Prevention Health-Related Quality of Life 14 Item Measure (CDC HRQOL14)) and a series of questions investigating how well patients are able to perform activities of daily living (ADLs) and instrumental activities of daily living (IADLs). These tests will be given at two time points, once before the surgery and then one month after surgery. We will look for changes in quality of life that may correlate with neuropsychometric test performance.

Peripheral serum samples will be drawn before induction, before cross-clamping the carotid artery, 15 minutes after cross-clamping the carotid artery and 24 hours after surgery. These samples will be analyzed for four different sets of markers of cerebral injury, one gene and two markers of systemic inflammation. Serum levels of neuron specific enolase (NSE) and protein S100B, a neuronal enzyme and glial cell component respectively, markers of cell injury will demonstrate cerebral injury

Patients will undergo intraoperative TCD (Transcranial Doppler) The TCD examination will assess the brain's ability to increase cerebral blood flow in response to a pharmacological challenge (CO2 inhalation). TCD measures the degree of cerebral vasodilation, identified as an increase in flow velocity on TCD. This "cerebrovascular reserve" we hypothesize will be able to predict performance on postoperative neuropsychometric tests

研究设计

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

入排标准

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

入选标准

  • ability to speak English
  • undergoing carotid endarterectomy procedure
  • undergoing lumbar laminectomy procedure

排除标准

  • history of permanent neurological impairment
  • Axis I psychiatric diagnosis or drug abuse

结局指标

主要结局

Percentage of Patients Having a Significant Change in Neuropsychometric Performance After Carotid Endarterectomy

时间窗: Baseline to Day 1

Neuropsychometric performance change is measured in Z-scores by compared to a reference group of elderly patients \> 60 years having "simple" spine surgery. The Z-scores were generated as follows. The mean and standard deviation (SD) of the change scores (neurocognitive performance after surgery minus neurocogntivie performance before surgery \[baseline\]) was calculated for the reference group of patients. The mean and SD from the reference group was used to generate Z-scores: The mean change score from the reference group of patients was subtracted from the change scores in for each CEA patient for each test and divided by the SD of the change scores of the reference group of patients.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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