Prospective Multicenter Registry On RadiaTion Dose Estimates Of Cardiac CT AngIOgraphy IN Daily Practice in 2017
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,502
- 试验地点
- 4
- 主要终点
- Radiation dose estimates of cardiac CT angiographies in daily practice
研究概览
简要总结
The "Prospective Multicenter Registry On RadiaTion Dose Estimates Of Cardiac CT AngIOgraphy IN Daily Practice in 2017" (PROTECTION-VI) study is a prospective registry and investigator-initiated initiative without third-party funding, which will collect and analyze the radiation dose exposure of Cardiac Computed Tomography Angiographic (CCTA) studies in current daily practice worldwide. Particularly, the study will assess the use of strategies for dose reduction during CCTA.
A decade ago, the multicentre observational PROTECTION-I study has revealed that the dose-length-product of CCTA ranges between 568 - 1259 mGy x cm with a median of 885 mGy x cm. This corresponds to an estimated effective dose of approximately 12 mSv. Since then a variety of techniques have been developed and enhanced in order to reduce radiation exposure during CCTA. Recent studies demonstrated feasibility of dramatically reduced effective radiation doses during CCTA (0,1 - 0,3 mSv). This has been executed in small cohorts of patients at scientific expert centers. However, it remains unclear, if such low-level radiation dose exposure may be achieved in clinical routine and if diagnostic image quality is maintained. In order to analyze the magnitude of radiation dose exposure of CCTA in today's clinical practice and the current use of dose-saving techniques, we designed the PROTECTION-VI study. Eventually, this study may contribute to further improving radiation dose exposure for patients undergoing CCTA.
详细描述
Cardiac CT angiography (CCTA) has emerged to a powerful and commonly used diagnostic tool for the evaluation of coronary artery disease. Advantages of CCTA are its non-invasive approach, widespread availability and high negative predictive value to rule out coronary artery disease. However, radiation exposure during CCTA needs to be considered, due to the potential risk of malignancy induction.
A decade ago, the multicentre observational PROTECTION I study has revealed that the dose-length-product of CCTA ranges between 568-1259 mGy x cm with a median of 885 mGy x cm. This corresponds to an estimated effective dose of approximately 12 mSv. Furthermore, PROTECTION I demonstrated an up to 7-fold variation of radiation dose between different study sites implicating the large potential for dose reduction. Finally, significant differences have been detected in the radiation exposures between CT systems from different vendors and application of dose-saving algorithms, implying that approaches for dose reduction with respect to hardware and software have also been of relevance in 2007.
Since then a variety of techniques have been developed and enhanced in order to reduce radiation exposure during CCTA. Earlier, ECG-controlled tube current modulation has been accepted to reduce radiation dose and was therefore used in ECG-gated retrospective cardiac spiral scanning.
Another dose-saving technique is the reduction of tube potential from conventionally 120 kVp to 100 kVp in non-obese patients. In the PROTECTION II trial we demonstrated that diagnostic image quality is being maintained with a reduction of tube potential to 100 kVp while radiation exposure was significantly reduced by 31%.
Development of prospective ECG-gated axial (sequential) scanning allowed further dose reduction, due to administration of radiation only at the end of diastole. In the PROTECTION III trial we could demonstrate that diagnostic image quality is being maintained with prospective ECG-gated axial scanning in patients with stable and low heart rates while radiation exposure was reduced by 69% when compared to conventional spiral scanning with retrospective ECG gating. Using prospectively ECG-triggered high-pitch spiral CCTA with image acquisition during only one cardiac cycle, additional dosage may be saved when used in selected patients with low and stable heart rates. However, a scan strategy with an attempt of high-pitch scanning first is vulnerable to motion artefacts and bears the risk of repeated scanning.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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 with a clinical indication for CCTA in order to evaluate the coronary arteries or other cardiac structures
- •Patients age > 18 years
- •Signed informed consent (if required by local IRB)
排除标准
- •Known allergy to contrast agent
结局指标
主要结局
Radiation dose estimates of cardiac CT angiographies in daily practice
时间窗: Baseline
Assessment after CT scan by radiologist or technical assistant, documented on questionnaire.
次要结局
- Assessment of CCTA image quality in relation to radiation dose(Baseline)
- Use of dose-saving strategies(Baseline)
- Sufficient result of the first CCTA scan or need for repeated scans(Baseline)
- Cardiac CT scan length and relationship between scan and heart length(Baseline)
- Comparison of dose estimates between different continents, CT vendors and CT systems(Baseline)
研究者
Thomas Stocker
Co-Principal Investigator
LMU Klinikum