Virtual Ward-Assisted Very earLy dIschArge of Low-rIsk STEMI patieNTs: the VALIANT-STEMI Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- 30-day all-cause mortality or any rehospitalisation
研究概览
简要总结
Observational studies have suggested that early discharge (24hrs with follow up virtually by telephone) of patients who are low risk and have had successful treatment following ST elevation myocardial infarction is safe. This has not been tested in a randomised controlled trial. In this trial the study team propose to identify low risk patients and randomise them to usual care or early discharge and follow up virtually by telephone. The primary endpoint would be readmission to hospital or all cause death up to 30 day following the event. If the outcome is positive, the study will assist early discharge of patients, reduce length of stay, potentially improve patient well being and have positive financial implications for the health service
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Successful revascularisation following STEMI
- •Zwolle score <=3
- •No bystander disease awaiting inpatient intervention at the time of screening or consent (so if they have had intervention to a bystander vessel before this they would be eligible)
排除标准
- •Haemodynamic instability (Killip class >I)
- •Left ventricular ejection fraction <45%<40%
- •Sustained ventricular or atrial arrhythmias requiring intervention
- •No support at home or social or physical circumstances preventing early discharge
- •Unable to use home monitoring equipment
- •Unwilling to consent or follow instructions
- •Patients visiting from out of our catchment area
- •Out-of hospital cardiac arrest
- •Patients repatriated to their local hospital within 24 hours
- •New or worsening renal failure (i.e. creatinine >=1.5x baseline)
结局指标
主要结局
30-day all-cause mortality or any rehospitalisation
时间窗: 24-48 hours
(time starts at admission of patient). No randomised controlled trials (RCTs) have compared 24-48 hours discharge to \>48 hours discharge in low-risk STEMI patients. To the knowledge there has been a prior meta-analysis included 5 RCTs comparing discharge at 48 to 72 hours versus \>72 hours and this was found to be safe(4). The 30-day event rate of any hospitalisation or all-cause death that was available from 3 RCTs was 31/489 (6.3%) in the routine care arm and 21/515 (4.1%) in the early discharge arm. For a non-inferiority design, assuming an event rate of 6% in the routine care arm and 4% in the very early discharge arm and a non-inferiority margin of 2.5%, 290 patients would be needed in each arm to provide 80% power, at 5% significance level. To allow for approximate 3-4% drop-out rate, it is intended to recruit 600 patients in total
次要结局
未报告次要终点