Dual-Energy CT Angiography in Suspected Pulmonary Embolism: Influence of Concentration of Contrast Materials on Image Quality and Diagnostic Performance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,100
- 试验地点
- 1
- 主要终点
- image quality evaluation of the CTPA images of 30% participants
研究概览
简要总结
The investigators aimed to compare the image quality and diagnostic performance of DECTPA using lower concentration iodine contrast materials and using normal concentration iodine contrast materials in the evaluation of suspected pulmonary embolism.
详细描述
All patients met the inclusion and exclusion criteria will be given written informed consensus. The enrolled patients will randomly receive one of the three injection protocols: A: 30mL Iomeprol (Iomeron 300, Bracco Imaging, Milano, Italia) injected at a flow rate of 4mL/s; B: 50mL Iomeprol (Iomeron 300, Bracco Imaging, Milano, Italia) injected at a flow rate of 4mL/s; C: 50mL Ioversol (Ioversol 350, Hengrui, Jiansun, China) injected at a flow rate of 4mL/s. A and B groups are both lower concentration iodine contrast material groups, with different total iodine loads.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years old
- •Clinical suspicion of pulmonary embolism suggests CTPA examination (Wells score>4 or D-2 polymer elevation)
- •Patient's general physical condition tolerates CTPA examination
排除标准
- •Allergy to iodine contrast agents
- •Hyperthyroidism
- •Pregnancy
- •Weight greater than 80kg
- •Heart failure patients, NYHA heart function level III or IV
结局指标
主要结局
image quality evaluation of the CTPA images of 30% participants
时间窗: through the CTPA examinations of 30% participants finished,, an average of six month
1. the mean CT number (in Hounsfield units) in the main pulmonary artery by using a region of interest of at least 1 square centimeter. 2. the CT number (in Hounsfield units) of peripheral pulmonary arteries close to the beginning and the end of each scan in a egmental or subsegmental artery at an apical and a basal section position. Because the caliber of the peripheral vessels was too small to reliably set an intraluminal region of interest to determine the mean CT number, the maximum CT number as a proxy for vascular attenuation should be chosen. 3. the images quality score for making a diagnosis other than PE ( using a five-point scale ranging from 1 to 5).
次要结局
- overall diagnostic performance for pulmonary embolism(CTPA examinations all participants are finished, an average of two month)
研究者
Peihua Lu
Director of Scientific Research Department
Wuxi People's Hospital