Randomized Evaluation Of Intracoronary Nitroprusside vs Adenosine After Thrombus-aspiration During Primary PErcutaneous Coronary Intervention for the Prevention of No Reflow in Acute Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Rate of major adverse cardiac events
研究概览
简要总结
The occurrence of no-reflow phenomenon after recanalization of the infarct related artery in acute myocardial infarction is described in up to 40% of cases. This event is associated with a worse prognosis at follow up and an unfavourable left ventricular remodelling . Two main pathogenetic mechanisms cause no-reflow: distal embolization and ischemia-reperfusion injury.
Due to the multifactorial pathogenesis of no-reflow during acute MI a combined mechanic and pharmacologic approach is believed to offer a better solution for achieving optimal microvascular reperfusion. Thus, in this randomized study we will assess the effect of nitroprusside or adenosine in adjunct to current best therapy (thrombus aspiration and IIb-IIIa antagonists) for ST elevation MI using ST segment resolution on standard 12 leads ECG as primary endpoint of myocardial reperfusion.
详细描述
The occurrence of no-reflow phenomenon after recanalization of the infarct related artery in acute myocardial infarction is described in up to 40% of cases. This event is associated with a worse prognosis at follow up and an unfavourable left ventricular remodelling. Two main pathogenetic mechanisms cause no-reflow: distal embolization and ischemia-reperfusion injury. Microembolization, which may be well prevented by a mechanic approach (device-based), play of course an important role in the no-reflow during primary percutaneous coronary intervention (primary PCI), however ischemia reperfusion injury is also independent of microemboli, indeed it occurs in the animal model after ligation of a non atherosclerotic coronary. Thrombus aspiration assisted primary intervention achieves complete resolution of the ST segment in 60% only of patients, whereas results of filter based studies have been substantially negative. A recent meta-analysis confirmed that thrombus aspiration improves microvascular perfusion, whereas filters do not.
Taken together available data suggest that other approach need to be tested in conjunction with the mechanical one to further improve microvascular integrity in this setting. Importantly, current antiplatelet therapy during reperfusion therapy for acute MI has not abolished the no-reflow phenomenon. Based on the experience matured in many studies of basic cardiology which investigated the model of ischemia and reperfusion various drugs have been tested in the human model.
Two drugs have emerged in particular as possible adjunct to reperfusion therapy: nitroprusside and adenosine. For the former good results have been obtained in small series, in contrast adenosine has been tested in a large randomized trial (AMISTAD-II trial) with controversial results when used at low dose. Another study using larger doses and a sub-analysis of a high dose group of the AMISTAD-II trial suggested a beneficial effect on infarct size. Importantly, none of this studies have been performed in the setting of thrombus aspiration.
Due to the multifactorial pathogenesis of no-reflow during acute MI a combined mechanic and pharmacologic approach is believed to offer a better solution for achieving optimal microvascular reperfusion. Thus, in this randomized study we will assess the effect of nitroprusside or adenosine in adjunct to current best therapy (thrombus aspiration and IIb-IIIa antagonists) for ST elevation MI using ST segment resolution on standard 12 leads ECG as primary endpoint of myocardial reperfusion.
Study Design
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Symptoms onset < 12 hours prior to enrollment
- •ST-segment elevation of at least 2 mm in two or more contiguous leads
- •TIMI flow 0-1 at baseline angiography
排除标准
- •Demographic, history and clinical examination
- •age less than 18 years
- •previous STEMI
- •patients presenting in cardiogenic shock
- •patients with renal failure
- •contraindications to contrast agents, which cannot be managed medically or study medications, including aspirin, clopidogrel and ticlopidine, and heparin
- •Electrocardiogram
- •left bundle branch block, paced rhythm, frequent ventricular ectopy, pre-excitation or other conditions or artifacts interfering with interpretation of ST segment resolution Angiography
- •culprit lesion located in a by-pass graft
- •stent thrombosis
- •culprit lesion non identified
- •left main disease
研究组 & 干预措施
1
Patients will receive intravenous administration of abciximab prior to PCI. After wire crossing, thrombus aspiration will be performed. The device will removed outside the body, flushed with saline and subsequently reintroduced in the culprit vessel beyond the occlusion site and intracoronary drugs will be selectively administered.
干预措施: adenosine (Drug)
2
Patients will receive intravenous administration of abciximab prior to PCI. After wire crossing, thrombus aspiration will be performed. The device will removed outside the body, flushed with saline and subsequently reintroduced in the culprit vessel beyond the occlusion site and intracoronary drugs will be selectively administered.
干预措施: nitroprusside (Drug)
3
Patients will receive intravenous administration of abciximab prior to PCI. After wire crossing, thrombus aspiration will be performed. The device will removed outside the body, flushed with saline and subsequently reintroduced in the culprit vessel beyond the occlusion site and intracoronary drugs will be selectively administered
干预措施: placebo (Drug)
结局指标
主要结局
Rate of major adverse cardiac events
时间窗: 6 months
次要结局
未报告次要终点
研究者
GIANPAOLO NICCOLI
Dott. Prof.
Catholic University of the Sacred Heart