Proposal for Collection of Patient Data to Aid in Design of an Observational Study (i.e. Preparatory to Research) Evaluating Risk of Cognitive Impairment After Surgical and Transcatheter Valve Replacement.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Montreal Cognitive Assessment
研究概览
简要总结
The investigators are conducting a pilot study to compare cognitive outcomes among Veterans with severe aortic valve stenosis who are scheduled to undergo either aortic valve replacement.
详细描述
The investigators are conducting a pilot study to compare cognitive outcomes in up to 60 Veterans with severe aortic valve stenosis who are scheduled to undergo either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) at the Minneapolis VA Health Care System. Participants will be administered a short battery of cognitive tests before and three months after TAVR or SAVR over/up to a two year study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 104 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe aortic stenosis (AVA: 1 cm2 and/or mean gradient =or > 40 mmHg and/or peak velocity > 4 m/s)
- •Scheduled to undergo either surgical or transcatheter aortic valve replacement at the Minneapolis VA Health Care System
排除标准
- •Severe cognitive impairment at baseline (i.e. unable to understand or follow-up study procedures)
- •Unable or unwilling to provide informed consent
研究组 & 干预措施
Surgical Aortic Valve Replacement
Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).
干预措施: Observational/Cognitive Assessment (Other)
Transcatheter Aortic Valve Replacement
Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).
干预措施: Observational/Cognitive Assessment (Other)
结局指标
主要结局
Montreal Cognitive Assessment
时间窗: Three Months
Estimate the means and standard deviations of changes in selected cognitive measures between baseline (pre-TAVR or pre-SAVR) and 3 months post-TAVR or post-SAVR, identify baseline correlates of those changes, and characterize baseline cognitive function and cognitive history of patients who undergo TAVR or SAVR.
Trail Making
时间窗: 3 months
次要结局
未报告次要终点
研究者
Santiago Garcia
MD
Minnesota Veterans Medical Research and Education Foundation