Statin and Post-interventional Coronary Microcirculation Dysfunction
Effect of Statin on the Post-interventional Coronary Microcirculation Dysfunction
研究概览
详细说明
Development of peri-procedural myocardial infarction following percutaneous coronary intervention (PCI) is not uncommon and affects long-term prognosis. Clinical studies have shown that pre-treatment with atorvastatin reduced peri-procedural myocardial infarction in patients with stable angina. The mechanism of peri-procedural myocardial infarction is presumed to be microvascular embolization. However the direct causal relationship between statin pretreatment and prevention of microvascular dysfunction has not been investigated yet.
In this study, we will recruit symptomatic angina patients who have clinical indication of coronary angiography. At the time of enrollment, patients will be randomly assigned to pre-treatment group (atorvastatin 80 mg/d for 4 days) or control group. Percutaneous coronary intervention (PCI) will be perfomed based on the result of diagnostic coronary angiography by decision of attending physician. When PCI is performed, fractional flow reserve (FFR) and index of microvascular resistance (IMR) will be measured before and after the procedure. Periprocedural myocardial infarction will be defined by post-PCI cardiac biomarker. All patients will be followed for adverse cardiac events for 1 year.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Gang nam-Gu, Ilwon-Dong
-
Seoul、Gang nam-Gu, Ilwon-Dong、大韩民国、135-710
- Samsung Medical Center
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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:
- A. Finished informed consent
- B. Stable angina with clinical indication of coronary angiography
- C. Age ≥ 21 year and ≤ 80 year
Exclusion Criteria:
- A.Without informed consent
- B.PCI target lesion is not adequate or not indicated for FFR/IMR study
- C.Prior myocardial infarction or interventional procedure for PCI target vessel
- D.Myocardial infarction within 30 days
- E.Usage of statin, current or within 1 month
- F.Prior bypass surgery
- G.Impaired renal function (Creatinine > 2.0 mg/dL)
- H.Impaired left ventricular function (ejection fraction < 40%)
- I.Active hepatitis or abnormal hepatic transaminase level (> 3 ULN)
- J.Contraindication for long-term antiplatelet agent or statin
- K.Planning or potential of pregnancy
- L.Neoplastic disease without evidence of treatment completion
- M.Impaired general condition
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 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 |
|---|---|
|
有源比较器:atorvastatin
PCI with atorvastatin pre-treatment group
|
其他名称:
|
|
无干预:control
PCI without atorvastatin pre-treatment group
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Post-procedural IMR of PCI target vessel Post-procedural IMR of PCI target vessel
大体时间:within 1 year after PCI
|
within 1 year after PCI
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Post-procedural troponin I
大体时间:within 1 year after PCI
|
within 1 year after PCI
|
|
Post-procedural FFR
大体时间:within 1 year after PCI
|
within 1 year after PCI
|
|
Post-procedural IMR comparison of target vessel with non-target vessel
大体时间:within 1 year after PCI
|
within 1 year after PCI
|
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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