Impact of Low Frame Rate Fluoroscopy and Cine-angiography on Reducing Operator and Patient Radiation Dose and Impact on Image Quality During Cardiac Catheterization
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Radiation Exposure to patient
研究概览
简要总结
The investigators sought to investigate the efficacy of low frame rate (fluoroscopy at 7.5 frames per second (FPS) and Cine at 10 pulse per second (PPS) vs. conventional (15 FPS and 15 PPS) on radiation dose to the patient and the operator during coronary angiography and intervention. In addition, investigators sought to qualitatively assess the effect, if any, of the low frame rate on angiographic image quality.
详细描述
Minimizing radiation exposure to patient and the operator is considered one of the primary safety concerns in the catheterization laboratory. Patients undergoing diagnostic angiography +/- ad hoc PCI or planned PCI, will be randomised to conventional settings (15 FPS and 15 PPS) or low frame rate settings (7.5 FPS and 15 PPS) or low Cine settings (7.5 FPS and 10 PPS). The patient radiation dose, patient radiation dose area product (DAP), and fluoroscopy time will be measured.
Statistical Analysis
Demographic and procedural variables will be presented as percentage (categorical variable) or mean ± SD (continuous variable). Patients will be randomized into three arms - a control arm and two intervention arms. The angiographic radiation protocol will adhere to standard practice in both fluoroscopy and cine images at 15 frames/second. The intervention arm will consist of two groups. Group 1 with fluoroscopy images set at 7.5 frames/second and cine images set at 15 frames/second and group 2 with fluoroscopy set at 7.5 frames/second and cine set at 10 frames/second.
Sample size calculations are based on assuming a reduction in radiation dose in group 1 of 10% and in group 2 of 20%. At 5% significance and 80% power, a sample size of 200 patients will be required in each intervention arm. Allowing for a 10% attrition rate, a sample size of 220 patients will be required in each intervention arm with 100 patients in the control arm.
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 or urgent cardiac catheterisation with or without ad-hoc PCI or planned PCI in the pre-specified catheterisation laboratories.
排除标准
- •Patients who undergo procedures other than diagnostic coronary angiography or intervention (e.g. electrophysiological procedures).
- •Patients participating in other research study requiring higher cine angiography.
- •ST-elevation Myocardial Infarction
结局指标
主要结局
Radiation Exposure to patient
时间窗: During Cardiac catheterization procedure
Radiation exposure to patient will be measured by Dose-Area product (DAP) collected during the procedure.
次要结局
- Image quality assessment of the coronary angiogram(12 months)
研究者
Vladimír Džavík
Director of Research and Innovation-Interventional Cardiology and Coronary Intensive Care Unit
University Health Network, Toronto