Pilot Study of Cognitive and Functional Outcomes Following TAVI
2016年10月14日 更新者:Sunnybrook Health Sciences Centre
Cognitive and Functional Outcomes Following Transcatheter Aortic Valve Implantation (TAVI): a Pilot Study
Narrowing of the aortic valve in the heart, known as severe aortic stenosis, can impede blood delivery and is associated with poor quality of life and death.
In the elderly with considerable medical burden, a relatively new non-invasive valve replacement technique called Transcatheter Aortic Valve Implantation (TAVI) can be used instead of open-heart surgery.
However, long term changes in cognition after TAVI remain unclear and previous studies have suggested an increased risk of cognitive decline in patients following the surgical procedure.
In this pilot study, the investigators will characterize changes in cognition, physical capacity, overall quality of life and neuropsychiatric symptoms (depression and apathy) over 6 months after TAVI.
研究概览
地位
完全的
条件
详细说明
Cardiovascular disease including valvular heart disease, contributes to an estimated 36% of all deaths over the age of 70.
In particular, severe aortic stenosis is the most common valvular heart disease in the elderly in the Western world and is associated with reduced quality of life and increased mortality.
TAVI has been shown to improve survival, with an all-cause mortality at 1 year similar to surgical aortic valve replacement (SAVR) with favourable outcomes long-term including improved functional capacity and quality of life.
Recent evidence from randomized controlled trials suggests an increased risk of neurological events (e.g.
cognitive decline) up to 1 year after TAVI in comparison to both SAVR and medical treatment.
Studies have shown no change in short-term memory, working memory, verbal learning, delayed recognition and verbal fluency 3 months after TAVI.
In addition, patients with severe aortic stenosis have an increased risk of mortality and future health complications.
This study will be an observational, prospective cohort pilot study to examine changes in cognitive performance and functional outcomes after TAVI.
We propose to recruit 34 patients for this study.
Cognitive performance will be measured using a standardized cognitive battery prior to TAVI and 6 months post-TAVI.
Functional capacity, changes in neuropsychiatric symptoms and quality of life will also be assessed prior to TAVI and 6 months post-TAVI.
We hypothesize there will a change in cognitive performance, functional capacity, mood outcomes and quality of life over 6 months after TAVI.
研究类型
观察性的
注册 (实际的)
14
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Ontario
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Toronto、Ontario、加拿大、M4N 3M5
- Sunnybrook Health Sciences Centre
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients with a diagnosis of severe symptomatic aortic stenosis (aortic valve area < 1 cm2, mean gradient across the aortic valve of 40 mm Hg or more and a peak aortic jet velocity of 4.0 m/s or more) undergoing transcatheter aortic valve implantation
描述
Inclusion Criteria:
- diagnosis of severe symptomatic aortic stenosis
- undergoing TAVI
- speak and understand English
Exclusion Criteria:
- emergency TAVI
- any medical conditions that will affect their ability to complete the protocol
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
---|
transcatheter aortic valve implantation
This study recruits individuals that are undergoing transcatheter aortic valve implantation.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Cognitive performance
大体时间:6 months
|
The 30-minute neuropsychiatric assessment battery recommended by NINDS-CSN (National Institute of Neurological Disorders and Stroke- Canadian Stroke Network) harmonized standards
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Functional capacity
大体时间:6 months
|
The Timed Up and Go Test (TUG) and Hand Grip Strength Test
|
6 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Quality of life
大体时间:6 months
|
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) and EQ-5D-5L questionnaires
|
6 months
|
Depression
大体时间:6 months
|
Centre for Epidemiologic Studies Depression Scale (CES-D)
|
6 months
|
Apathy
大体时间:6 months
|
Apathy Evaluation Scale (AES)
|
6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Krista L Lanctôt, PhD、Sunnybrook Health Sciences Centre
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年2月1日
初级完成 (实际的)
2015年9月1日
研究完成 (实际的)
2015年9月1日
研究注册日期
首次提交
2014年3月14日
首先提交符合 QC 标准的
2014年3月14日
首次发布 (估计)
2014年3月18日
研究记录更新
最后更新发布 (估计)
2016年10月17日
上次提交的符合 QC 标准的更新
2016年10月14日
最后验证
2016年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.