Prospective Randomized Trial On Radiation Dose Estimates Of CT Angiography In Patients Applying Iterative Image Reconstruction Techniques - The PROTECTION V Study - (PROTECTION-V)
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.
研究概览
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Bavaria
-
Muenchen、Bavaria、德国、80636
- 招聘中
- Deutsches Herzzentrum Muenchen
-
首席研究员：
- Joerg Hausleiter, MD
-
接触：
- Joerg Hausleiter, MD
- 电话号码：1585 49 89 1218
- 邮箱：hausleiter@dhm.mhn.de
-
接触：
- Simon Deseive, MD
- 电话号码：49 89 1218
- 邮箱：deseive@dhm.mhn.de
-
副研究员：
- Simon Deseive, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patients with an indication for a coronary CT angiography (planned evaluation of the coronary arteries)
- signed informed consent
- stable sinus rhythm
- age > 18 years
Exclusion Criteria:
- known allergy to contrast agents.
- patients with known coronary artery disease
- pregnancy
- no stable sinus rhythm
- coronary ct examinations not focussing on coronary arteries
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Control group
Conventional coronary CT angiography using standard reconstruction technique (filtered back projection).
|
Conventional coronary CT angiography using standard reconstruction technique (filtered back projection).
|
|
实验性的：Intervention group
Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm.
|
Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Image quality
大体时间：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.
|
1 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quantitative image quality parameters
大体时间：1 month
|
Quantitative image quality parameters, e.g.
image noise, signal and contrast intensity, signal- and contrast-to-noise-ratios
|
1 month
|
|
Prevalence of non-diagnostic examinations
大体时间：1 month
|
Prevalence of non-diagnostic examinations in both study arms.
|
1 month
|
|
Prevalence of coronary artery plaques
大体时间：1 month
|
Prevalence of coronary artery plaques and coronary artery plaques characteristics (non-calcified, calcified, mixed) in both study arms.
|
1 month
|
|
Prevalence of follow-up examinations
大体时间：1 month
|
Prevalence of follow-up examinations in both study arms.
|
1 month
|
|
Radiation dose
大体时间：1 month
|
Radiation dose in both study arms.
|
1 month
|
合作者和调查者
调查人员
- 首席研究员：Joerg Hausleiter, MD、Deutsches Herzzentrum Muenchen
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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