Phase 4 Study of Primary Angioplasty Combined Distal Injection of Abciximab to Thrombus and Aspiration With Catheter
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Infarct size
研究概览
简要总结
Aims: (to prove that) The distal injection of IIb IIIa platelet receptor blocker to the thrombus occlusion is better than normal injection during primary percutaneous intervention (PCI) for the treatment of acute myocardial infarction. Using this modification of injection method the investigators can achieve less microvascular damage and a reduction of the infarct size with a significant improvement of the outcome at six months.
详细描述
There are some evidence about the utilization of aspiration catheter (Indication class IIb with level of evidence B in European Guidelines) and intravenous abciximab (indication Class IIa an level of evidence A in European Guidelines) in primary PTCA. Direct intracoronary injection of abciximab get smaller infarct size than intravenous injection. The hypothesis of our study are that direct distal injection of abciximab by aspiration catheter will be better than proximal intracoronary injection with reduction in infarct size and microvascular damage quantified by Magnetic resonance (MR) and 6 months mortality.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myocardial infarction patients between 3 and 12 hours after symptoms onset
排除标准
- •Hemodynamic instability
- •TIMI flow 2 or 3
- •Life expectance less than 6 months
- •Contraindication to AAS, clopidogrel or abciximab
- •Severe tortuosity of occluded vessel
结局指标
主要结局
Infarct size
时间窗: Between 2 and 9 days after primary ptca
Infarct size quantified by MR
次要结局
- Major Adverse Cardiac and Cerebrovascular Events (MACCE)(6 months)
研究者
J.Moreu
Director catheterization laboratory
Hospital Virgen de la Salud