Safety And Feasibility of Early DischargE - a Prospective And Randomized Trial of Low-risk Primary PCI Patients (The SAFE-DEPART Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Safety: All-cause mortality
研究概览
简要总结
The purpose of this study is to determine if early hospital discharge (at 48-72 hours), is feasible, safe, cost-effective, and/or improves compliance with medications, positive lifestyle changes and quality-of-life, in low-risk patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention (primary PCI).
详细描述
Patients with acute ST-segment elevation myocardial infarction (STEMI) have traditionally been hospitalized for at least 5-7 days to monitor for serious complications, including heart failure, arrhythmias, re-infarction and death. With the advent of primary percutaneous coronary intervention (PCI) as the treatment of choice for STEMI, fewer patients are completing their infarcts and the incidence of complications is decreasing. The Zwolle Primary PCI Index is one of several externally validated risk scores that can be used to identify low-risk primary PCI patients who can safely be discharged at 48-72 hours. Recent reviews have found that a majority of primary PCI patients with risk scores that deem them "low-risk" are kept in hospital longer than predicted by these scores.
SAFE-DEPART is a trial where low-risk primary and rescue PCI patients will be randomized either to an intervention arm (early hospital discharge, early outpatient follow-up with a nurse practitioner) or to standard of care (no recommended discharge date, no outpatient follow-up with a nurse practitioner). At 6 weeks time, a blinded research assistant will contact patients and collect data on feasibility, safety, quality-of-life, and cost-effectiveness outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with ST-elevation myocardial infarction (STEMI)
- •Treatment with either primary or rescue PCI
- •Zwolle risk score <= 3
排除标准
- •Developed MI while in hospital for another reason
- •Time from angioplasty to enrollment > 24 hours
结局指标
主要结局
Safety: All-cause mortality
时间窗: 6 weeks
Safety: Readmission for any of CHF, unstable angina, arrhythmia, re-infarction, revascularization, stroke, or major bleeding requiring transfusion
时间窗: 6 weeks
Feasibility: Proportion of patients in the intervention group discharged within 72 hours ("feasible" if >= 70%)
Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 3 days of discharge ("feasible" if >= 80%)
Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 5 days of discharge ("feasible" if >= 90%)
次要结局
- Quality of life, as measured by the SF-36 questionnaire(6 weeks)
- Compliance with medications(6 weeks)
- Compliance with smoking cessation(6 weeks)
- Attendance at first cardiac rehabilitation session(6 weeks)
- Cost-effectiveness(6 weeks)