Omission of Prophylactic Verapamil Use in Transradial Coronary Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 591
- 试验地点
- 1
- 主要终点
- Rate of Access Site Conversions
研究概览
简要总结
Background Verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm. However, verapamil may have side effects and is contraindicated in some clinical settings.
Methods: During an investigator-initiated, randomized, double-blind trial, we evaluate the need for preventive verapamil administration. After vascular access is established, patients receive either 5 mg verapamil (n=297) or placebo (n=294). We compare the rate of access site conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural and fluoroscopic times, contrast volume, and subjective pain are investigated as secondary end points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
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
- •patients undergoing transradial coronary angiography and/or percutaneous coronary intervention
- •successful cannulation of the radial artery
排除标准
- •reduced left ventricular systolic function (LVEF<35%)
- •significant aortic stenosis
- •bradycardia (<50/min.)
- •myocardial infarction complicated by cardiogenic shock and/or high grade AV block
研究组 & 干预措施
Verapamil
干预措施: Verapamil (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of Access Site Conversions
时间窗: Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.
次要结局
- Rate of Code Breaks(Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.)
- Rate of Vasodilator Use(Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.)
- Procedural Time(Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.)
- Fluoroscopic Time(Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.)
- Contrast Volume(The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.)
- Subjective Pain(Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.)
研究者
Istvan Hizoh, MD, PhD
Senior Consultant
State Health Center, Hungary