A Randomized Comparison of Nitroglycerin Versus Placebo as Spasmolytic Regimen to Prevent Moderate to Severe Radial Artery Spasm in Radial Center
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The incidence of Moderate to severe radial artery spasm
研究概览
简要总结
The investigators will investigate whether administration of Nitroglycerin (NTG) as spasmolytic regimen reduces the incidence of moderate to severe radial artery spasm (RAS) in patients undergoing transradial catheterization in radial center.
详细描述
Patients will be randomized to receive either 200 microgram NTG or placebo (saline) at the beginning of the procedure soon after radial sheath placement. The operators will be blinded to both assignment. The primary outcome is the incidence of moderate to severe RAS evaluated by the operators during the radial procedure.
Both NTG and placebo will be administered using an identical syringe to keep the operators blinded to the treatment allocation. Radial angiogram is mandatory to measure the diameter of both radial and ulnar arteries. Doppler ultrasound of the radial artery will be examined at the day after the procedure.
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 (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing transradial catheterisation using proximal radial artery puncture technique
排除标准
- •Blood pressure <100 mmHg
- •Refuse to participate
研究组 & 干预措施
200 microgram NTG
200 microgram NTG through the radial sheath
干预措施: NTG 1 MG/ML Injectable Solution (Drug)
Saline
Saline infusion through the radial sheath
干预措施: NTG 1 MG/ML Injectable Solution (Drug)
结局指标
主要结局
The incidence of Moderate to severe radial artery spasm
时间窗: During the index procedure
arm pain associated with catheter manipulation (RAS grade 2 to 4)
次要结局
未报告次要终点
研究者
Surya Dharma, MD, PhD
MD, PhD
Hermina Heart Center Kemayoran