A Randomized Trial of Rosuvastatin Loading Combined With Early hydrAtion Versus Standard-of-care Medications for the Prevention of CIAKI in Patient With AMI Undergoing Emergency PCI (TRACK-AMI)
2019年9月17日 更新者：Han Yaling、Shenyang Northern Hospital
A Randomized Trial of Rosuvastatin Loading Combined With Early hydrAtion Versus Standard-of-care Medications for the Prevention of Contrast Induced Acute Kidney Injury in Patient With Acute Myocardial Infarction Undergoing Emergency Percutaneous Coronary Intervention (TRACK-AMI)
The CIAKI,as the third complication of PCI, was associated with adverse cardiac events after procedure.
Moreover, because the rate of periprocedure hydration is inadequate in STEMI patients before primary PCI, the incidence of CIAKI is higher significantly in these patients.
The cardiovascular pleiotropic effects of statins in addition to lipid have been widely concerned.
The previous studies demonstrated usage of statin in periprocedure could decrease the risk of CIAKI.
Compared with hydration, the usage of statin to prevention CIAKI show the advantages in clinical practice, for example，there is no need to consider the cardiac function.The optimal strategies for preventting CIAKI in STEMI patients undergoing primary PCI needed further studies to explore.
What's more, whether a synergistic effect of hydration and statin or not is unknown.
研究概览
地位
撤销
研究类型
介入性
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。
学习地点
-
-
Liaoning
-
Shenyang、Liaoning、中国
- The General Hospital of Shenyang Millitary Region
-
-
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 至 80年 (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:
- Age 18-80 years old
- The STEMI patients within 12 h of onset(or within 12-24 h of onset with chest pain and persistent ST-segment elevation or the presence of a new LBBB);
- The patients planned primary PCI;
- At least one of the following:
Diabetes mellitus, Chronic Kidney Disease, Female, Elder(Age≥65), Hypertension class 3, Congestive heart failure
• Voluntary signature of informed consent
Exclusion Criteria:
- Type 2 Myocardial infarction secondary to an ischaemic imbalance
- Intolerance of statin or iodine contrast
- eGFR<30ml/min
- Administration of any iodinated (e.g.CT angiography) within 14 days before enrollment
- Hepatic dysfunction, ALT 3 times greater than upper normal limit
- Thyreoid insufficiency
- Hemodynamic instability
- Have received PCI or CABG within 30 day before enrollment
- Plan to perform any coronary angiography or PCI within 30 days
- Have received any statins within 7 days before enrollment
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：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 |
|---|---|
|
实验性的：hydration plus rosuvastatin therapy
|
In experimental group,a loading dose of rosuvastatin 20mg then 10 mg daily followed for at least 7 days and hydration（3ml/kg/h）last 12 hours after randomized
|
|
有源比较器：Standard therapy
No statin within 12 h after randomization, hydration at physicians' discretion, but no more than 1ml/kg/h.
|
Prohibition of use any statins from randomized to 12 hours after procedure; The hydration or not is determined by physicians but 1 ml/kg/h at most.
|
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 |
|---|---|---|
|
CIAKI
大体时间：7 days
|
CIAKI, defined an Absolute Increase in SCr ≥0.5mg/dL（≥44.2μmmol/L）or
a ≥ 25% Increase in SCr From Baseline to 7 days After the Procedure
|
7 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The peak value of Scr
大体时间：withtin 7 days before randomized
|
withtin 7 days before randomized
|
|
|
The rate of Aggravated Heart Function
大体时间：withtin 30 days before randomized
|
Aggravated at Least 1 Class of Heart Function
|
withtin 30 days before randomized
|
|
The rate of Hospitalization for Aggravated Renal Function, Acute Renal Failure, Dialysis or Hemofiltration
大体时间：withtin 30 days before randomized
|
withtin 30 days before randomized
|
|
|
the level of hsCRP
大体时间：withtin 7 days before randomized
|
withtin 7 days before randomized
|
|
|
The Composite of all-cause death, MI, stroke, and TVR
大体时间：withtin 30 days before randomized
|
withtin 30 days before randomized
|
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。
调查人员
- 首席研究员：Yaling Han, MD、The General Hospital of Shenyang Millitary Region
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 (预期的)
2019年2月20日
初级完成 (预期的)
2019年12月31日
研究完成 (预期的)
2019年12月31日
研究注册日期
首次提交
2018年4月25日
首先提交符合 QC 标准的
2018年5月3日
首次发布 (实际的)
2018年5月16日
研究记录更新
最后更新发布 (实际的)
2019年9月19日
上次提交的符合 QC 标准的更新
2019年9月17日
最后验证
2019年9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.