Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 14
- 主要终点
- Post-procedural mortality or major morbidity
研究概览
简要总结
Frailty is a state of decreased physiologic reserves and vulnerability to stressors. Several tools exist to measure frailty, some based on physical tests and others on questionnaires, yet there is no agreement on which tool to recommend. This multi-center prospective cohort study is aimed at comparing various frailty assessment tools to determine which best predicts death or major complications after cardiac surgery or transcatheter intervention. The population of interest is elderly patients with severe aortic stenosis undergoing surgical or transcatheter aortic valve replacement. The frailty assessment tools under investigation include composite frailty scales, physical performance tests, muscle mass, and biomarker expression. The overall objective is to improve our ability to predict risk by measuring frailty using the optimal tool in elderly cardiovascular patients.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥70 years (a site-specific substudy at the JGH will enroll ages ≥21 years)
- •Referred for surgical or transcatheter AVR (with or without concomitant revascularization)
- •Signed informed consent
排除标准
- •Emergency surgery
- •Clinical instability: decompensated heart failure, active ischemia, unstable vital signs
- •Severe neuropsychiatric impairment
- •Not English or French speaking
- •Replacement of >1 valve or aortic surgery
结局指标
主要结局
Post-procedural mortality or major morbidity
时间窗: 30 days
Mortality is defined as death from any cause. Major morbidity is defined as an aggregate of the Society of Thoracic Surgeons (STS) and Valve Academic Research Consortium (VARC) composite endpoints. Additionally, the individual components of this composite endpoint will be examined.
次要结局
- All-cause mortality(6-12 months)
- Length of stay(30 days)
- Functional status(6-12 months)
研究者
Jonathan Afilalo
MD MSc FACC FRCPC
Jewish General Hospital