ECG-guided Immediate pRimAry Percutaneous Coronary Intervention for Culprit Vessel Using a Transradial Single Guiding Catheter to Reduce Door to Device Time: RAPID II Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 560
- 试验地点
- 2
- 主要终点
- door to device (D2D) time
研究概览
简要总结
No consensus exists about which coronary artery should be firstly catheterized in primary percutaneous coronary intervention (PCI). The aim of the present study was to compare door-to-balloon time (D2B) of ECG guided immediate infarct-related artery (IRA) PCI with traditional complete coronary angiography followed by PCI for the treatment of ST segment elevation myocardial infarction (STEMI) patients. Primary endpoint is door to device (D2D) time. Secondary end-points are: puncture to device (P2D) time,first medical contact to device (FMC2D) time,incidence of radial artery spasm and occlusion, contrast amount, fluoroscopy time, cumulative air kerma(CAK) and dose area product(DAP).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be > 18 years of age
- •Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation≥2mm in two continuous precordial leads or ST elevations≥1mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI
- •Symptoms ≥ 30 min and ≤12 hours
- •Patient and treating interventional cardiologist agree for randomization
- •Patient provides written informed consent
- •Diagnostic and therapeutic intervention performed through transradial artery approach
- •Palpable radial artery.
排除标准
- •Concurrent participation in other investigational study
- •Current platelet count <100 x 10^9cells/L or Hgb <10 g/dL
- •Absence of radial artery pulsation
- •Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy
- •Uncontrolled hypertension
- •Prior CABG surgery
- •Fibrinolytic therapy for current MI treatment
- •patient have a life expectancy of <180days
结局指标
主要结局
door to device (D2D) time
时间窗: 24hours
time patient's arrival at our hospital to first device (balloon,aspiration catheter or stent) use
次要结局
- first medical contact to device (FMC2D) time(24hours)
- puncture to device (P2D) time(24hours)
- incidence of radial artery occlusion(inhospital (an expected average of 5 days),30day,12month)
- incidence of radial artery spasm(during the procedure (time from the guide catheter inserted to guide catheter removed))
- fluoroscopy time(1 hour)
- cumulative air kerma(CAK) and dose area product(DAP).(1 hour)