Prospective Randomized Trial On Radiation Dose Estimates Of CT Angiography In Patients Applying Iterative Image Reconstruction Techniques - The PROTECTION V Study -
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Image quality
研究概览
简要总结
The objective of this study is to compare a standard coronary CT angiography scan protocol with conventional image reconstruction with a scan protocol using reduced tube current and a new image reconstruction algorithm. The investigators hypothesize that the image quality of the new scan protocol is not inferior, while radiation dose estimates are reduced by around 30%.
Secondary endpoints of the study include quantitative image quality parameters, prevalence of non-diagnostic studies, prevalence of coronary artery plaques and plaque characteristics (calcified, non-calcified, mixed) and prevalence of follow-up examinations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with an indication for a coronary CT angiography (planned evaluation of the coronary arteries)
- •signed informed consent
- •stable sinus rhythm
- •age > 18 years
排除标准
- •known allergy to contrast agents.
- •patients with known coronary artery disease
- •no stable sinus rhythm
- •coronary ct examinations not focussing on coronary arteries
研究组 & 干预措施
Control group
Conventional coronary CT angiography using standard reconstruction technique (filtered back projection).
干预措施: Control group (Radiation)
Intervention group
Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm.
干预措施: Intervention group (Radiation)
结局指标
主要结局
Image quality
时间窗: 1 month
Compared with a conventional scan protocol the use of a new scan protocol using iterative image reconstruction and reduced tube current is associated with a comparable diagnostic image quality, while the radiation dose estimates are significantly reduced.
次要结局
- Quantitative image quality parameters(1 month)
- Prevalence of coronary artery plaques(1 month)
- Prevalence of non-diagnostic examinations(1 month)
- Radiation dose(1 month)
- Prevalence of follow-up examinations(1 month)