Optimal Strategy of Primary PCI for Left Main Coronary Artery Occlusion Induced AMI (OPTIMAL)
Optimal Strategy of Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction Due to Unprotected Left Main Coronary Artery Occlusion
研究概览
详细说明
Primary percutaneous coronary intervention for patients presented with acute myocardial infarction caused by left main coronary artery occlusion is associated with significantly higher mortality and risks of major cardiac adverse events. Deferred stent implantation may improve prognosis of primary PCI through reducing distal embolization and no-reflow phenomenon. There is no randomized clinical trial focuses on the effect and outcome of deferred stent implantation on primary PCI for left main coronary artery occlusion in contrast with conventional strategy.
This prospective, multicenter, randomized trial is aimed to compare immediate stenting with deferred stenting for LM-AMI with 30 centers in China involved. We hope to determine whether deferred stenting is superior to conventional strategy for primary PCI of AMI caused by left main coronary artery occlusion in improving long-term clinical outcomes and cardiac function.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Shanghai
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Shanghai、Shanghai、中国、200032
- 招聘中
- Zhongshan Hospital
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首席研究员：
- Junbo Ge, M.D.
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接触：
- Feng Zhang, M.D.
- 电话号码：13917149007
- 邮箱：zhang.feng@zs-hospital.sh.cn
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接触：
- Yang Gao, M.D.
- 电话号码：18801970322
- 邮箱：gysc20@163.com
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副研究员：
- Feng Zhang, M.D.
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副研究员：
- Yang Gao, M.D.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Clinical diagnosis of acute myocardial infarction occured within 12 hours
- Left main coronary artery occlusion confirmed by angiography
- Left main coronary artery occlusion (TIMI flow 0,1 or 2) confirmed by primary angiography, TIMI flow grade 3 achieved after pretreatment of thrombus aspiration or balloon dilatation
Exclusion Criteria:
- Life expectancy less than 1 years
- Cardiogenic shock
- Chronic kidney disease, stage 4 by KDOQI(GFR<30ml/min)
- Contraindications to aspirin or other anti-platelet drugs
- Allergy to contrast agent, rapamycin or paclitaxel
- Patients who are included in other ongoing trials
- Pregnant female
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Deferred stent implantation
Drug-eluting stents are implanted 4-10 days after primary angiography and restoration of blood flow in left main coroanry artery in a secondary PCI
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Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted 4-10 days after restoration of blood flow in left main coronary artery in a secondary PCI.
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有源比较器：Immediate stent implantation
Drug-eluting stents are implanted immediately after primary angiography and restoration of blood flow in left main coroanry artery
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Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted immediately after restoration of blood flow in left main coronary artery in a secondary PCI.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Composite of cardiac death and recurrent myocardial infarction
大体时间：30 days after primary angiography
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Recorded in follow-up
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30 days after primary angiography
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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All cause death, cardiac death, recurrent myocardial infarction, target vessel revascularization
大体时间：30 days after primary angiography
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Recorded in follow-up
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30 days after primary angiography
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Residual stenosis of left main coronary artery
大体时间：Immediately after stent implantation and 12 months after primary angiography
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Measured through angiography
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Immediately after stent implantation and 12 months after primary angiography
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Left ventricular ejection fraction
大体时间：30 days and 12 months after primary angiography
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Measured through echocardiogram
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30 days and 12 months after primary angiography
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合作者和调查者
调查人员
- 首席研究员：Junbo Ge, M.D.、Zhongshan Hospital,Shanghai
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Deferred stent implantation的临床试验
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Johns Hopkins University完全的
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Weill Medical College of Cornell University终止
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Ludek StehlikUniversity Hospital Olomouc; University Hospital, Motol; Ministry of Health, Czech Republic暂停