Neuropsychological Testing in Patients Undergoing TAVI
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- net change in neuropsychological tests between baseline and day 180 from TAVI
研究概览
简要总结
The purpose of this study is to examine the neuropsychological effects of transvascular aortic valve implantation (TAVI). Patients undergoing TAVI usually suffer from congestive heart failure and low cardiac output which may limit their cognitive abilities. TAVI results in significant improvements in cardiac function and therefore may improve cognitive functions. However, TAVI may also be associated with stroke and may therefore have a negative impact on cognition. Therefore, in this study the investigators wish to perform a battery of standardized neuropsychological tests before and after TAVI to test the net effects of TAVI on cognitive performance over time.
The investigators plan to include all patients planned to have TAVI in the study and to test them before, 3,7, 30 and 360 days post TAVI with a standardized battery of test.
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
- 否
入选标准
- •All patients with severe aortic stenosis that are candidates for TAVI
- •Able to perform the testing
- •Able to sign informed consent
排除标准
- •Language barriers precluding the administration of the testing
- •Existing dementia
- •Existing disease limiting life expectancy to less than 180 days
结局指标
主要结局
net change in neuropsychological tests between baseline and day 180 from TAVI
时间窗: 180 days
The study will assess changes in cognitive performance between baseline (prior to TAVI) and 180 days after TAVI
次要结局
- net difference between cognitive measures before TAVI and at day 30 after TAVI(30 days)
研究者
Ronen Leker
Director - Stroke Center
Hadassah Medical Organization