A Randomized Control Trial of Intracoronary Reopro to Improve Coronary Microvascular Function
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Index of Microvascular Resistance
研究概览
简要总结
Microvascular dysfunction is a key determinant of pathogenesis and outcome in patients suffering an acute myocardial infarction.
The investigators hypothesise that treatment with intracoronary abciximab, a potent anti platelet agent, at the time of coronary stent insertion, will improve microvascular function.
详细描述
The index of microcirculatory resistance (IMR), an invasive measure of coronary microvascular function, correlates with clinical outcomes in patients with stable angina and ST elevation myocardial infarction. The glycoprotein IIb/IIIa receptor inhibitor, abciximab, improves coronary microvascular function and reduces major cardiac adverse events in patients with acute coronary syndromes. This study will investigate whether an intracoronary bolus of abciximab in patients with non-ST elevation myocardial infarction decreases IMR and improves microvascular function.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with acute coronary syndromes
排除标准
- •Patient with untreated malignancy, disseminated malignancy, active inflammatory diseases, active infectious diseases patients unable to give informed consent Patients with STEMI
研究组 & 干预措施
Intracoronary abciximab (Reopro)
Intracoronary abciximab (Reopro)
干预措施: Abciximab (Drug)
结局指标
主要结局
Index of Microvascular Resistance
时间窗: within 3 hours
We will assess IMR in the catheterisation laboratory immediately before PCI, then intracoronary reopro or placebo will be administered and we will re-assess IMR 15 minutes post delivery of the study drug. Finally we will perform PCI and immediately measure IMR post-procedure.
次要结局
- Incidence of periprocedural myocardial infarction(within 24 hours)
研究者
A/P Andrew Wilson
Associate Professor
University of Melbourne