Randomized Comparison Between a Strategy of Intervention in Frailty Versus the Usual Care in Frail Patients After an Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change on frailty status according to the Fried scale
研究概览
简要总结
Frailty has been associated to a worse outcome in acute coronary syndromes, but the best management of frail patients after an acute coronary syndrome remains unknown. The aim was to investigate the benefit of an intervention on frailty in frail patients after an acute myocardial infarction.
Patients survivors after an acute myocardial infarction (with and without ST-segment elevation), older than 70 years and with pre-frailty (1-2 points) or frailty (≥3 points) according to the Fried's scale measured 24 hours before hospital discharge, will be included. The participants will be randomized to 2 strategies: a) intervention on frailty in addition to the usual care by the cardiologist, and b) conventional strategy consisting only of the usual care by the cardiologist. A multidisciplinary team (physicians, nurses and physiotherapists and nutritionists) will carry out the intervention on frailty The study contemplates a 2-year inclusion period and a 3rd year for the follow-up of the last included patient. The main outcome will be the frailty status (Fried's scale) at 3 months and 1 year. The secondary endpoint will be the clinical events, both cardiovascular and not cardiovascular events, including recurrent events (cumulative events analysis), for the total follow up (3 years in the case of the first included patient). The hypothesis is that an intervention on frailty will improve frailty status and the clinical outcomes in frail patients after an acute myocardial infarction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Admission for acute myocardial infarction and survivors in the hospitalization phase
- •Age =>70 years
- •Prefrail or frail status (Fried scale =>1 points)
排除标准
- •Cognitive impairment (Pfeiffer test)
- •Severe concomitant disease that could hamper the participation in the study
- •Patient refusal to participate
结局指标
主要结局
Change on frailty status according to the Fried scale
时间窗: 3 months and 1 year
Points in the Fried scale
次要结局
- Change of Quality of life (EUROQOL)(3 months and 1 year)
- All-cause mortality(Up to 3 years)
- Change of Functional capacity (walk distance test)(3 months and 1 year)
- Change of Nutritional status (Mini Nutritional Assessment)(3 months and 1 year)
- Ischemic events (reinfarction or postdischarge revascularization)(Up to 3 years)
- Readmission for acute heart failure(Up to 3 years)
- Readmission for non-cardiac causes(Up to 3 years)
- Total cardiac (cardiac death, reinfarction, postdischarge revascularization, readmission for acute heart failure, readmission for other cardiac cause) and non-cardiac (all-cause mortality or readmission for non-cardiac cause) clinical events(Up to 3 years)
研究者
Juan Sanchis
Prof
University of Valencia