A Novel Approach to Reduce Radial Artery Occlusion After Trans-Radial Catheterization: Post-Procedural/Pre-Hemostasis Intra-Arterial Nitroglycerin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,706
- 试验地点
- 1
- 主要终点
- Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular high resolution ultrasound
研究概览
简要总结
Trans-radial approach (TRA) has becoming popular and widely adopted over the last decade. However, radial artery occlusion (RAO) continues to be one of the limitation of trans-radial access and potentially limits the radial artery as an access site in the future. Several strategies have been used to decrease the incidence of RAO including the use of anticoagulation, maintenance of patency during hemostasis, or shortening the duration of compression. Currently, there is no data whether vasoactive pharmacological therapy such as nitroglycerin administered intra-arterially at the end of the procedure may reduce the incidence of RAO. It is hypothesized that the addition of nitroglycerin (nitric oxide donor) at the end of a TRA procedure may reduce the incidence of RAO.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sequential patients undergoing trans-radial catheterization in the institution will be consented to be randomized to receive either 500 microgram nitroglycerin (Group A) or a placebo (Group B) administered intra-arterially through the sheath at the end of the procedure.
排除标准
- •Patients with cardiogenic shock or hemodynamically unstable
- •Unable to tolerate nitrates
研究组 & 干预措施
500 microgram of Nitroglycerin
500 mcg nitroglycerin was given intra-arterially through the sheath at the end of a transradial procedure
干预措施: 500 microgram of Nitroglycerin (Drug)
Saline 5 mL
0,9% Saline 5 mL was given intra-arterially through the sheath at the end of a transradial procedure
干预措施: Saline 5 mL (Drug)
结局指标
主要结局
Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular high resolution ultrasound
时间窗: One Day After the Index Procedure
次要结局
未报告次要终点
研究者
Surya Dharma, MD, PhD
MD, PhD
National Cardiovascular Center Harapan Kita Hospital Indonesia