To Investigate Whether Single Catheter Primary PCI Method Can Reduce the Time Required for Primary PCI in Cases of ST Elevation Myocardial Infarction.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 430
- 试验地点
- 2
- 主要终点
- Sheath-to-first device activation time
研究概览
简要总结
The goal of this clinical trial is to test reducing procedure time of percutaneous coronary intervention (PCI) in ST elevation myocardial infarction by single catheter PCI (SC-PCI) method. The main question it aims to answer is:
• [question 1] SC-PCI method is skipping catheter exchange with use of a right and left dual purpose universal guiding catheter Ikari Left curve. Does SC-PCI method reduce PCI procedure time? Participants will be randomly assigned to SC-PCI method or conventional method and emergency PCI is performed.
Researchers will compare time from sheath insertion to first device activation between the SC-PCI method and the conventional method.
详细描述
<<Background>>
Acute ST-segment elevation myocardial infarction is a disease of high acute-phase mortality rate, but the life can be saved by implementing emergency percutaneous coronary intervention (PCI). Its efficacy is higher than that of thrombolytic therapy. Moreover, shortening of total ischemia time reduces the mortality rate and can promote recovery of cardiac function. The total ischemia time can be classified into the time from onset to arrival at hospital and the time from arrival at hospital to recanalization of coronary artery (Door-to-balloon time), and shortening of time in all steps is recommended. Various methods, including the part of transportation to hospital and from arrival at hospital to treatment room, are proposed, but there is no effective method for shortening of procedure time for PCI.
Since the right and left dual-purpose universal guiding catheter can be inserted into both the left and right coronary arteries, the time for replacement of catheter can be shortened. Since IKARI Curve catheter is considered to be the most excellent catheter as the universal guiding catheter, it is considered useful for shortening of reperfusion time in myocardial infarction.
<<Objectives.>>
There are a lot of reports that decreased mortality and improvement of cardiac function are observed by shortening of the time from onset of acute myocardial infarction to recanalization. However, shortening of catheterization time, a part of the time, has not been examined. In 60 patients in a single-center retrospective study performed in Tokai University, the time from arterial puncture to reperfusion was shortened, and the time from arrival at hospital to reperfusion was also shortened. In 1275 patients in a multi-center retrospective study, moreover, the time from arterial puncture to reperfusion was significantly shortened by 4 minutes, and a significant decrease was also observed in the time from arrival at hospital to reperfusion. The Door-to-balloon time at this time was 68±46 minutes in the SC-PCI group and 76±51 minutes by the conventional method. Moreover, the time from insertion of sheath to balloon was 19±14 minutes in the SC-PCI group and 23±14 minutes by the conventional method. In addition, shortening of fluoroscopy time was also observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 21 years or older
- •Acute ST-segment elevation myocardial infarction
- •Patients indicated for Primary PCI within 12 hours after onset
排除标准
- •Patients with shock requiring insertion of Impella, ECMO or IABP before PCI
- •Patients requiring cardiopulmonary resuscitation due to cardiac arrest
- •Patients requiring temporary pacemaker due to bradycardia
- •Patients undergoing dialysis
- •Patients judged by the attending physician to be inappropriate for registration
结局指标
主要结局
Sheath-to-first device activation time
时间窗: the end of PCI
Time from insertion of sheath to reperfusion treatment apparatus (First device activation)
次要结局
- Total ischemia time(the end of PCI)
- Fluoroscopy time and fluoroscopy dose(the end of PCI)
- All-cause mortality and cardiovascular mortality at 30 days(At 30 days from the onset of STEMI)
- Amount of contrast medium(the end of PCI)
- Hospital expense(30 days)
- Success rate of SC-PCI method(the end of PCI)
- Number of catheters used(the end of PCI)
- Door-to-balloon time(the end of PCI)
- Hemorrhagic complication rate at 30 days(At 30 days from the onset of STEMI)
- All-cause mortality and cardiovascular mortality at 1 year(1 year after the randomization)
研究者
Sho Torii
Associate Professor, Department of Cardiology
Tokai University