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)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- CIAKI
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
hydration plus rosuvastatin therapy
- After randomized，hydration（3ml/kg/h, if patients had LVEF<40%, 1.5 ml/kg/h）last 12 hours;
- After randomized，a loading dose of rosuvastatin 20mg then 10 mg daily followed for at least 7 days.
干预措施: hydration plus rosuvastatin therapy (Drug)
Standard therapy
No statin within 12 h after randomization, hydration at physicians' discretion, but no more than 1ml/kg/h.
干预措施: Standard therapy (Drug)
结局指标
主要结局
CIAKI
时间窗: 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
次要结局
- the level of hsCRP(withtin 7 days before randomized)
- The rate of Hospitalization for Aggravated Renal Function, Acute Renal Failure, Dialysis or Hemofiltration(withtin 30 days before randomized)
- The peak value of Scr(withtin 7 days before randomized)
- The rate of Aggravated Heart Function(withtin 30 days before randomized)
- The Composite of all-cause death, MI, stroke, and TVR(withtin 30 days before randomized)
研究者
Han Yaling
Prof.
Shenyang Northern Hospital