The MATRIX OCT Substudy
Residual thrombosis of stent struts may occur after the end of primary angioplasty and determine distal embolization and further myocardial damage. Bivalirudin is considered the most appropriate antithrombotic drug in the setting of primary PCI, but an initial increase in stent thrombosis has been reported. In order to overcome this potential adverse event, a prolonged infusion of bivalirudin after the end of PCI has been proposed.
This aim of this study is to test whether the use of long-term bivalirudin infusion, as compared to the intra-procedural only administration, reduces residual thrombosis of stent struts evaluated by optical coherence tomography (OCT) at the end of primary PCI and at 3-5 days follow-up.
A subgroup of patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study will be selected showing the following inclusion criteria:
- patients affected by STEMI undergoing primary PCI with stent implantation and randomised to bivalirudin treatment,
- patients who, in addition to the infarct related lesion, show at least one critical stenosis of other coronary vessels suitable for staged-PCI,
- patients whose anatomy is suitable for OCT evaluation.
研究概览
地位
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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Grosseto、意大利、58100
- 招聘中
- Misericordia Hospital
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接触:
- Ugo Limbruno, MD,PhD, FESC
- 电话号码:+390564483465
- 邮箱:ulimbru@tin.it
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接触:
- Andrea Picchi, MD, PhD
- 电话号码:+3905644834645
- 邮箱:andre.picchi@gmail.com
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study showing the following features:
- patients affected by STEMI undergoing primary PCI with stent implantation and randomised to bivalirudin treatment,
- patients who, in addition to the infarct related lesion, show at least one critical stenosis of other coronary vessels suitable for staged-PCI,
- patients with a coronary anatomy suitable for OCT evaluation.
Exclusion Criteria:
- The same criteria used in MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study.
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 |
---|---|
实验性的:Prolonged bivalirudin infusion
Bivalirudin infusion is prolonged after the end of primary PCI
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有源比较器:Intra-procedural bivalirudin infusion
Bivalirudin infusion is stopped at the end of primary PCI
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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 |
---|---|
Change in Minimal Flow Area (MinFA) measured at the end of primary PCI and at 4/5-day follow-up
大体时间:At the end of primary PCI and 4-5 day later
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At the end of primary PCI and 4-5 day later
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次要结果测量
结果测量 |
大体时间 |
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Change in the number of stent cross sections with a thrombotic area > 10% measured at the end of prymary PCI and at 4/5-day follow-up
大体时间:Athe end of primary PCI and 4/5 days later
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Athe end of primary PCI and 4/5 days later
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (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 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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