Atorvastatin for Reduction of Myocardial Damage During Angiography and Its Mechanism Associated With IMR
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- perioperative myocardial infarction
研究概览
简要总结
The purpose of this study is to determine whether preoperative loading dose atorvastatin can prevent perioperative myocardial infarction during angiography and main adverse cardiac events 1 month after operation in stable angina, unstable angina and acute non-ST-segment elevation myocardial infarction patients undergoing elective coronary angiography and PCI, and determine whether its mechanisms are associated with microcirculation resistance.
详细描述
With 20 years of popularity of the clinical applications of percutaneous coronary intervention (PCI), increasing attention has been paid to postoperative myocardial injury (MI) after PCI. NAPLES II1 and ARMYDA2Studies have shown that loading dose statin therapy before PCI for ACS patients can reduce perioperative myocardial infarction and major adverse cardiac events (MACE) and mortality 1 year after PCI. The core mechanism about the effects of statins on the clinical outcomes above-mentioned, which can not been completely explained by the lipid-lowering effect, so far have not been discovered in previous studies. Thus the interest of some researchers turned to the other point of view, such as coronary microcirculation. MI after PCI is a kind of non-ST-segment elevation myocardial infarction (NSTEMI) related to coronary microcirculation, which can not been detected by coronary angiography, but can be detected by index of microcirculatory resistance (IMR) examination.
In this study, we will recruit stable angina, unstable angina and acute non-ST-segment elevation myocardial infarction patients who have been confirmed by coronary angiography. At the time of enrollment, patients will be randomly assigned to loading dose group (atorvastatin 80 mg 12 hours before PCI and 40 mg 2 hours before PCI and then 20mg/d after PCI) or control group (atorvastatin 20 mg 12 hours before PCI and then 20mg/d after PCI). When PCI is performed, 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 month.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stable angina
- •Patients with unstable angina patients
- •Patients with acute non STsegment elevation myocardial infarction
- •Patients willing to accept the need regular follow-up of this study
- •Patients 18-75 years of age
- •Patients who signed an informed consent form
排除标准
- •ST segment elevation acute myocardial infarction
- •Emergency coronary angiography in patients
- •Patients with abnormal liver function
- •Heavily calcified, distortions coronary lesions
- •LVEF <30% of patients
- •eGFR<30ml/min/1.73 Square meters
- •Liver disease or a history of muscle disease
研究组 & 干预措施
loading dose atorvastatin
For the arm of loading dose atorvastatin, patients will be treated with 80 mg atorvastatin 12 hours before PCI and 40 mg atorvastatin 2 hours before PCI and then 20mg/d after PCI.
干预措施: loading dose atorvastatin (Drug)
conventional dose atorvastatin
For the arm of conventional dose atorvastatin, patients will be treated with 20 mg atorvastatin 12 hours before PCI and then 20mg/d after PCI.
干预措施: conventional dose atorvastatin (Drug)
结局指标
主要结局
perioperative myocardial infarction
时间窗: 1 month after PCI
次要结局
- major adverse cardiac events (MACE) 1 month after PCI(1 month)
- mortality 1 month after PCI(1 month)
研究者
Zhishan SUN
Central South university
Central South University
