Multivessel Stenting Versus Staged Revascularization With Zotarolimus-eluting Stent for STEMI (ZES for STEMI)
2013年1月30日 更新者：Dr. Vladimir Ganyukov、Russian Academy of Medical Sciences
Multivessel Stenting and Staged Revascularization for ST-elevation Myocardial Infarction Patients With Resolute Integrity Stents
The purpose of this study is to determine outcomes (death, myocardial infarction, target vessel revascularization (TVR), non-target vessel revascularization (non-TVR), stent-thrombosis) of 120 consecutive patients with ST elevation myocardial infarction and multivessel coronary artery disease undergoing multivessel stenting or staged percutaneous coronary intervention with Zotarolimus-eluting stents
研究概览
地位
未知
详细说明
Multivessel coronary artery disease has been reported to occur in 40 to 67% of ST elevation myocardial infarction (STEMI) patients.
Multivessel coronary artery disease (MVCD) patients, who have experienced STEMI, are at a high risk of major cardiovascular events (MACE) within one year after primary PCI.
While MACE incidence in patients with one-vessel coronary artery disease is about 14.5%, patients with two- and three-vessel lesions experience MACE in 19.5% and 23.6% of cases, respectively.
The risk of death in a 5-year follow-up increases two-fold in MVCD patients.
This risk can be partly explained by slower recovery of left ventricular function and progression of left ventricular pathological remodeling process after MI.
In addition, the mere presence of MVCD has been shown to be associated with MACE development in the long-term period.
There are several treatment strategies for ST-elevation myocardial infarction (STEMI) patients with MVCD: infarct related artery (IRA)-only percutaneous coronary intervention (PCI), multivessel stenting in the primary PCI setting and staged revascularisation.
The current guidelines for STEMI revascularisation give no definite instructions on the need for concurrent non-IRA intervention in patients with stable haemodynamics.
At present, there are not clinical trials testing the current Zotarolimus-eluting stents (ZES) in STEMI patients with MVCD undergoing primary PCI for different strategies of revascularization.
研究类型
介入性
注册 (预期的)
120
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Vladimir Ganyukov, MD, PhD
- 电话号码：+79131273905
- 邮箱：ganyukov@mail.ru
研究联系人备份
- 姓名：Roman Tarasov, MD, PhD
- 电话号码：+79235260446
- 邮箱：roman.tarasov@mail.ru
学习地点
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Kemerovo Region
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Kemerovo、Kemerovo Region、俄罗斯联邦、650002
- 招聘中
- State Research Institute for Complex Issues of Cardiovascular Diseases
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接触：
- Vladimir Ganyukov, MD, PhD
- 电话号码：+79131273905
- 邮箱：ganyukov@mail.ru
-
接触：
- Roman Tarasov, MD, PhD
- 电话号码：+79235260446
- 邮箱：roman.tarasov@mail.ru
-
首席研究员：
- Vladimir Ganyukov, MD, PhD
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Subject must be at least 18 years of age.
- Subject is able to verbally confirm understandings of risks, benefits of treatment of either multivessel stenting or staged PCI using the zotarolimus-eluting stent (Resolute Integrity™ Stent, Medtronic) and he or she or his or her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject must have significant stenoses (≥ 70%) of two or more than two of coronary arteries and requiring primary PCI for acute ST elevation myocardial infarction (STEMI) within 12hrs
- Target lesion(s) must be located in a native coronary artery with visually estimated diameter of less than 2.5 mm and more than 4.0 mm.
- Target lesion(s) must be amenable for percutaneous coronary intervention
Exclusion Criteria:
- The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin Aspirin Both Clopidogrel and Ticlopidine, Zotarolimus
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 6 months post enrollment.
- Non-cardiac comorbid conditions are present with life expectancy over 1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Acute heart failure Killip III-IV
- ≥ 50% left main stenosis
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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 |
|---|---|
|
实验性的：Multivessel stenting
This group comprises the patients who undergo a one-time primary percutaneous coronary intervention (PCI) of the culprit and nonculprit lesions
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Multivessel stenting or Staged PCI with Zotarolimus-eluting coronary stent in STEMI patients
其他名称：
|
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有源比较器：Staged revascularization
This group comprises the patients who undergo PCI of only the culprit lesion and staged nonculprit PCI at a later date (3-15 days)
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Multivessel stenting or Staged PCI with Zotarolimus-eluting coronary stent in STEMI patients
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
All death including cardiac and non cardiac death
大体时间：30 days, 6 months and 12 montrhs
|
30 days, 6 months and 12 montrhs
|
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Recurrent MI
大体时间：30 days, 6 months and 12 months
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30 days, 6 months and 12 months
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Any revascularizations (TLR or TVR)
大体时间：30 days, 6 months and 12 months
|
30 days, 6 months and 12 months
|
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Composite rate of all death, any MI and any repeat revascularization
大体时间：30 days, 6 months and 12 months
|
30 days, 6 months and 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
stent thrombosis
大体时间：30 days. 6 months and 12 months
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The incidence of stent thrombosis was assessed throughout the follow-up period, according to the conventional ARC (Academic Research Consortium) classification.
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30 days. 6 months and 12 months
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Non-TVR
大体时间：30 days, 6 months and 12 months
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Any repeat revascularization of non target vessels
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30 days, 6 months and 12 months
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其他结果措施
结果测量 |
大体时间 |
|---|---|
|
Composite rate of all death, any MI and any repeat revascularization
大体时间：30 days, 6 months and 12 months
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30 days, 6 months and 12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年9月1日
初级完成 (预期的)
2013年12月1日
研究完成 (预期的)
2014年12月1日
研究注册日期
首次提交
2013年1月29日
首先提交符合 QC 标准的
2013年1月30日
首次发布 (估计)
2013年2月1日
研究记录更新
最后更新发布 (估计)
2013年2月1日
上次提交的符合 QC 标准的更新
2013年1月30日
最后验证
2013年1月1日
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.
Zotarolimus-eluting coronary stent的临床试验
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Seoul National University Bundang Hospital完全的