Low Rate Fluoroscopy at Reducing Operator and Patient Radiation Dose During Transradial Coronary Diagnostic Angiography and Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 385
- 试验地点
- 2
- 主要终点
- Radiation Exposure
研究概览
简要总结
Objectives: To determine the efficacy of low rate fluoroscopy at 7.5 frames per second (FPS) vs. conventional 15 FPS for reduction of operator and patient radiation dose during diagnostic coronary angiography and percutaneous coronary intervention via the transradial approach.
Background: Transradial approach for cardiac catheterization is potentially associated with increased radiation exposure. Low rate fluoroscopy has potential to reduce radiation exposure.
详细描述
Methods: Patients undergoing transradial approach diagnostic angiography ± ad hoc PCI, wil be randomized to fluoroscopy at 7.5 FPS vs. 15 FPS prior to procedure. Both 7.5 and 15 FPS fluoroscopy protocols will be configured with a fixed dose per pulse of 40 nGy. Primary endpoints will be operator radiation dose (measured with dosimeter attached to the left side of thyroid shield in µSv), patient radiation dose (expressed as dose-area product in μGy.m2), and fluoroscopy time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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 elective, urgent or emergent cardiac catheterization procedures with or without ad hoc PCI, via transradial approach are eligible.
排除标准
- •non-transradial access and 2) participation in research project(s) requiring higher ie 30 FPS cine angiography.
结局指标
主要结局
Radiation Exposure
时间窗: During Cardiac Catheterization
Operator radiation dose (measured with dosimeter attached to the left side of thyroid shield, in µSv)
次要结局
- Procedural Characteristics(During Cardiac Catheterization)
研究者
Olivier F. Bertrand
Study Principal Investigator
Laval University