NCT00910481已完成不适用
Balloon Pump Assisted Coronary Intervention Study
British Cardiovascular Intervention Society1 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2005年12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
- 301
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiac and Cerebrovascular Events
研究概览
简要总结
This study will test the hypothesis that elective use of the Intra-Aortic Balloon Pump (IABP) in patients undergoing high-risk Percutaneous Coronary Intervention (PCI) will reduce the rate of in-hospital major adverse cardiac and cerebrovascular events compared to patients who are managed without planned insertion of IABP.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •impaired left ventricular function (Ejection Fraction < 30%)
- •large area of myocardium at risk (BCIS-1 Myocardial Jeopardy Score ≥ 8/12)
排除标准
- •cardiogenic shock
- •acute STEMI within previous 48 hours
- •complications of recent AMI (including ventricular septal defect, severe mitral regurgitation, intractable ventricular arrhythmias)
- •contraindications to IABP use (including significant iliac or femoral arterial disease and more than mild aortic regurgitation)
结局指标
主要结局
Major Adverse Cardiac and Cerebrovascular Events
时间窗: Hospital discharge or 28 days following PCI, whichever occurs sooner
(composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event)
次要结局
- All-cause Mortality(6-months following randomization)
- Major Procedural Complications(Duration of PCI procedure)
- Transient Ischemic Attack(Hospital Discharge or 28 days following PCI (whichever occurs sooner))
- Procedural Success(Duration of PCI procedure)
- Bleeding Complications (Major and Minor)(Hospital Discharge or 28 days following PCI (whichever occurs sooner))
- Access Site Complications(Hospital Discharge or 28 days following PCI (whichever occurs sooner))
- Length of Hospital Stay(Hospital Discharge)
研究者
Dr Divaka Perera
Professor of Cardiology
British Cardiovascular Intervention Society
研究点 (1)
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