NCT01860079已完成不适用
Early Discharge After Primary Percutaneous Coronary Intervention: A Prospective Randomized Multi-center Trial (the EDAP PCI Trial)
Acibadem University3 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2013年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 900
- 试验地点
- 3
- 主要终点
- All Cause Mortality and Readmission at 30 Days.
研究概览
简要总结
- When Primary percutaneous coronary intervention (PPCI) is performed expeditiously and at a high-volume centre, it is the optimal approach for ST elevation myocardial infarction (STEMI) . In contrast to the clarity of how to treat STEMI, there is no clear definition for when to discharge and which patient to discharge.
- An early discharge strategy may be desired by all parties (financial health care provider, treating physician, nurse, patient, patient's relatives)involved in STEMI.
- The main goal in our study is to test the hypothesis that an early discharge strategy within 48-56 hours in patients with successful PPCI is as safe as in those patients who stay longer (96-120 hours) as of a standard procedure.
详细描述
- Primary percutaneous coronary intervention (PPCI) has become the optimal reperfusion strategy for ST elevation myocardial infarction (STEMI) when the procedure is performed expeditiously and at a high-volume centre.In contrast to the clarity of how to treat STEMI, there is no clear definition for when to discharge and which patient to discharge.
- It is conceivable to discharge patients with successful PPCI as early as possible, because a hospital stay longer than needed may create undesirable outcomes in terms of hospital infections, psychosocial reasons, adequate mobilization and patient comfort. In many tertiary centres with a busy PPCI programme insufficient bed capacity is an ongoing concern and threatens the continuous acceptance of new cases of acute infarctions. In addition, it has been indicated that an early discharge policy may lead to a substantial cost saving.
- Although much work has been done in developing and validating risk scores that identify low risk patients, data on the implementation of early discharge strategies have been quite limited There are 3 randomised trials investigating the possibility of early discharge after PPCI. However, certain limitations of these studies are preventing to implement an early discharge strategy in all-comers, particularly because of the underrepresentation of older patients in clinical trials. The verification of this policy is also needed in patients with multivessel disease. The first prospective randomized trial, the PAMI II,7 is partly obsolete as major changes have been made in PPCI with respect to devices and adjunctive medication. The other two randomized trials were single-center pilot studies with small number of patients.
- Therefore, the above mentioned literature information warrants to test the reproducibility of safety endpoints in a large scale multicenter trial, prior to application of the early discharge strategy in clinical practice.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent and subsequent written agreement of a family member (confirming good social background)
- •Acute STEMI, defined as >30 minutes of continuous typical chest pain and ST-segment elevation ≥2 mm in two contiguous electrocardiography leads and /or left bundle branch block within 12 hours of symptom onset.
- •Haemodynamically stable Angiographically
- •Successful PPCI procedure (TIMI 2-3 flow and %<20 residual stenosis) and an uneventful 24 hour follow up period
- •Single epicardial artery to be treated
- •Telephone contact between the patient and PCI center after discharge is available 24 hours daily
排除标准
- •Inability to consent
- •Patients treated with thrombolytic agents for the index STEMI
- •Cardiogenic shock,
- •Stroke within a month,
- •Signs of heart failure (Killip II-IV)
- •Hypotension (<100 mmHg SBP) persisting after PPCI
- •Chest pain recurrence
- •Clinically significant arrhythmia (requiring treatment) occurring >6 hours after PPCI.
结局指标
主要结局
All Cause Mortality and Readmission at 30 Days.
时间窗: 30 DAYS
The primary end points were all cause mortality by 1 month and readmission due to reinfarction, unstable angina, arrhythmia, congestive heart failure, revascularization, stroke or major bleeding at 1 month.
次要结局
未报告次要终点
研究者
研究点 (3)
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