Radiation Protection With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Total Radiation Dose
研究概览
简要总结
RADIATION PROTECT is a randomized, controlled trial of patients undergoing coronary angiography or PCI with or without a pelvic lead shield. Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures.
It is hypothesized that routine use of the pelvic lead shield and radiation protection cap during these procedures will reduce the amount of radiation in which the interventional cardiologists get exposed.
详细描述
Patients referred for coronary angiography or PCI will be randomized to undergo their procedure with or without the pelvic lead shield and the operator will wear a radiation protection cap.
Clinical efficacy will be assessed based on the total radiation dose that the interventional cardiologist got exposed to as well as a secondary outcome measuring the total radiation exposure dose per minute.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient referred for coronary angiography or Percutaneous Coronary Intervention (PCI)
排除标准
- •Age ≤ 18 years
- •Previous inclusion in RADIATION PROTECT trial
结局指标
主要结局
Total Radiation Dose
时间窗: Duration of Procedure (an expected average of 30 minutes)
1. The total radiation dose that the interventional cardiologist got exposed to as read by dosimeters (µSv) at left breast. 2. The difference between both groups in radiation dose that the interventional cardiologist got exposed to divided by Air Kerma (µSv/mGy). 3. For the radiation protection cap, the primary outcome is the difference between total radiation dose as measured by two dosimeters (µSv) at left temporal region of the head of the interventional cardiologist (one on the outside of the radiation protection cap and the other one on the inside of the cap).
次要结局
- Radiation Exposure Dose per minute(Duration of Procedure (an expected average of 30 minutes))
研究者
Dr. Sanjit S. Jolly
Interventional Cardiologist, Associate Professor
Population Health Research Institute