A Randomized Comparison of Post-procedural/Pre-hemostasis Intraarterial Nitroglycerin Versus Nicardipine to Reduce Radial Artery Occlusion After Transradial Catheterization
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- The absence of antegrade radial artery flow by doppler evaluation
研究概览
简要总结
A total of 600 patients undergoing coronary procedures via transradial access using 6F sheath were randomized at the end of the procedure to receive either 250-µg nicardipine or 500-µg nitroglycerin administered to the radial artery through the radial sheath before sheath removal. A continuous patent hemostasis was applied in each patient with the use of an oximetry to maintain an oxygen saturation of >95%, measured in the finger of the accessed arm until compression device was totally removed. The primary outcome is early RAO which was evaluated by color duplex ultrasonography of the accessed arteries at the day after the radial procedure. Secondary outcome was the change of blood pressure at 2-3 minutes after drug administration. Radial artery angiogram was performed after radial sheath insertion and doppler ultrasound of the accesed radial artery was examined at the day after the procedure.
详细描述
Doppler ultrasound of the accessed artery was performed at the day after the radial procedure in all patients. The absence or presence of antegrade flow in the radial artery will be examined while compressing the ulnar artery as previously described.
The internal lumen radial artery diameter was evaluated by doppler ultrasound as the distance between the inner walls of the artery by personnel that are blinded to the study protocol.
Radial artery angiogram was performed soon after radial sheath insertion and the radial artery diameter was measured in AP projection in all patients.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 16 Years 至 85 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing transradial catheterization
排除标准
- •Systolic blood pressure < 100 mmHg
研究组 & 干预措施
Nitroglycerin
500 microgram intraarterial Nitroglycerin
干预措施: Nitroglycerin (Drug)
Nicardipine
200 microgram intraraterial Nicardipine
干预措施: Nitroglycerin (Drug)
结局指标
主要结局
The absence of antegrade radial artery flow by doppler evaluation
时间窗: 24 hour
The absence of radial artery flow by doppler evaluation
Blood pressure change
时间窗: 2 minutes after drugs administration
Blood pressure change after drugs administration
次要结局
未报告次要终点
研究者
Surya Dharma, MD, PhD
NONERAO study
Hermina Heart Center Kemayoran
