NCT01868256Unknown不适用
Safety of a Early Discharge Strategy in Patients With Low-risk ST-segment Elevation Myocardial Infarction Treated With Primary Coronary Intervention: a Randomized Controlled Trial
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau2 个研究点 分布在 1 个国家目标入组 1,558 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,558
- 试验地点
- 2
- 主要终点
- All cause mortality, new acute myocardial infarction, new unstable angina, heart failure, ventricular arrhythmias, stroke and severe bleeding.
研究概览
简要总结
- Objectives: The primary objective of this study is to evaluate the safety of an early discharge strategy in patients with low risk ST-elevation myocardial infarction (STEMI), treated with primary percutaneous coronary intervention (PPCI), compared to a conventional strategy.
- Methodology: Unicentric, randomized, controlled, non-inferiority and open label clinical trial. The investigators will compare an early discharge strategy (≤72 hours) with a conventional strategy (discharge according to treating physician's criterion). Inclusion criteria will be: low risk (Zwolle risk score ≤3) STEMI treated with PPCI within 24 hours from symptoms onset. Exclusion criteria will be: arrhythmias (ventricular tachycardia or fibrillation, asystole, pulseless electrical activity, advanced atrio-ventricular block), mechanical complications (cardiac tamponade, free-wall or septal rupture, acute mitral regurgitation, pericarditis), severe or moderate bleeding (according to the GUSTO criteria), complications related to vascular access of the procedure, acute kidney failure, infection, heart failure. Sample size will be 1558 subjects (n=779 per group). The investigators will study demographic, clinical, biochemical, echocardiographic and angiographic variables. The primary endpoint will be a composite of death, reinfarction, new angina, heart failure, ventricular arrhythmias, stroke and severe bleeding. The secondary endpoint will include each of the items of the primary endpoint and quality of life and functional capacity questionnaire SF-36. Finally, the investigators will analyze the degree of compliance with the European Society of Cardiology guidelines on STEMI and the rate of hospitalization-related complications. Follow up will be at 30 days.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •low risk (Zwolle risk score ≤3) STEMI treated with PPCI within 24 hours from symptoms onset
- •Informed consent
排除标准
- •arrhythmias (ventricular tachycardia or fibrillation, asystole, pulseless electrical activity, advanced atrio-ventricular block)
- •mechanical complications (cardiac tamponade, free-wall or septal rupture, acute mitral regurgitation, pericarditis)
- •severe or moderate bleeding (according to the GUSTO criteria)
- •complications related to vascular access of the procedure
- •acute kidney failure
- •infection
- •heart failure
结局指标
主要结局
All cause mortality, new acute myocardial infarction, new unstable angina, heart failure, ventricular arrhythmias, stroke and severe bleeding.
时间窗: 1 month
Composite primary end-point
次要结局
- All cause mortality(1 month)
- Myocardial infarction(1 month)
- Unstable angina(1 month)
- Heart failure(1 month)
- Ventricular arrhythmias(1 month)
- Stroke(1 month)
- Severe bleeding(1 month)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve ReplacementAortic Valve StenosisNCT03600935BC Centre for Improved Cardiovascular Health315
已完成
不适用
Safety And Feasibility of Early DischargE - a Prospective And Randomized Trial of Low-risk Primary Percutaneous Coronary Intervention (PCI) PatientsMyocardial InfarctionNCT00474214Hamilton Health Sciences Corporation54
招募中
不适用
Validation of the Perth Chest Pain RuleChest PainSuspected Acute Coronary SyndromeCardiovascular - Coronary heart diseasePublic Health - Health service researchACTRN12611000566932Yusuf Nagree600
已完成
不适用
Verification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial InfarctionAcute Myocardial Infarction With ST-segment ElevationPrimary Percutaneous Coronary InterventionEarly DischargeCoronary Artery DiseaseNCT02023983Kamil Novobílský151
Unknown
不适用
Safety of an Early Discharge Protocol After Sleeve GastrectomyMorbid ObesitySleeve GastrectomyEarly DischargeSafety IssuesNCT03070457Hospital Universitari de Bellvitge60