Prospective Evaluation of Neurocognition in Patients Undergoing Transcatheter Aortic Valve Replacement: Periprocedural Changes and Predictors of Improvement
概览
- 阶段
- 不适用
- 干预措施
- 5 minute Montreal Cognitive Assessment (mini MoCA)
- 疾病 / 适应症
- Mild Cognitive Impairment
- 发起方
- Baylor Research Institute
- 入组人数
- 81
- 试验地点
- 4
- 主要终点
- Neurocognition measured by Mini MoCA at 30 days post TAVR
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
This trail is for patients with mild cognitive impairment (MCI) who are receiving a transcatheter aortic valve replacement (TAVR). We will assess changes in neurocognition following TAVR with the 5 minute Montreal Cognitive Assessment (mini MoCA) when comparing pre procedure with post procedure assessments.
详细描述
Patients with mild cognitive impairment who are being treated with a TAVR can choose to take part in this trial. This trial will prospectively enroll patients at 4 Baylor Scott \& White facilities. 80 patients will be enrolled between all sites. The mini MoCA will be conducted at the following time points: pre TAVR, 30 days post TAVR, and 6 months post TAVR. All other data will be collected from patient charts and are considered standard part of their care.
研究者
入排标准
入选标准
- •Age 18 years or older
- •Undergoing a TAVR procedure
- •Possible MCI as determined by procedures already used in the TAVR clinics, including 1 of the 4:
- •History of MCI, dementia, or stroke (CVA or TIA)
- •History of prescription treatment for MCI
- •Discretion of the investigator, physician, or clinic staff
- •Scores 25 or less on the mini MoCA exam
排除标准
- •1\. In another research study that doesn't allow dual enrolment, or dual enrolment has not been granted.
研究组 & 干预措施
Patients with Mild Cognitive Impairment Undergoing TAVR
Patients will be treated with standard of care. In addition, patients will complete the mini MoCA at 3 time points
干预措施: 5 minute Montreal Cognitive Assessment (mini MoCA)
结局指标
主要结局
Neurocognition measured by Mini MoCA at 30 days post TAVR
时间窗: 30 days post TAVR
Changes in neurocognition compared to baseline at 30 days
次要结局
- Neurocognition measured by Mini MoCA at 6 months post TAVR(6 months post TAVR)