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临床试验/NCT03622060
NCT03622060已完成3 期

A Randomized Comparison of Post-procedural/Pre-hemostasis Intraarterial Nitroglycerin Versus Nicardipine to Reduce Radial Artery Occlusion After Transradial Catheterization

Hermina Heart Center Kemayoran1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2018年6月4日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

500 microgram intraarterial Nitroglycerin

干预措施: Nitroglycerin (Drug)

Nicardipine

Placebo Comparator

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

发起方
Hermina Heart Center Kemayoran
申办方类型
Other
责任方
Principal Investigator
主要研究者

Surya Dharma, MD, PhD

NONERAO study

Hermina Heart Center Kemayoran

研究点 (1)

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