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临床试验/NCT02291718
NCT02291718已完成4 期

Comparison of High Iodine Concentration Contrast Material (Isovue 370) vs Standard Protocol (Isovue 300) in Thoracoabdominal Aortic Computed Tomographic Angiography (CTA) for Radiation Dose Reduction

Duke University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
150
试验地点
1
主要终点
Radiation Dose

研究概览

简要总结

The purpose of this study is to compare the contrast agents and imaging techniques used for thoracoabdominal aortic imaging in CT. Imaging parameters and contrast volume are changed and adjusted based on the contrast agent, since contrast agents have varying iodine concentrations. If the contrast iodine concentration is higher, it may be possible to adjust the imaging parameters and lower the overall radiation dose to the patient.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • Patients undergoing thoracoabdominal aortic (TAA) CTA
  • Able to provide informed consent
  • Body Mass Index (BMI) equal to or less than 30

排除标准

  • Creatinine greater than 2.0
  • Allergy to contrast media
  • Pregnant women

研究组 & 干预措施

Isovue 370 60mL

Active Comparator

Isovue 370 60mL injected 100 kVp 240 mAs

干预措施: Isovue (Drug)

Isovue 300 75mL

Active Comparator

Isovue 300 75mL injected 120 kVp 250 mAs

干预措施: Isovue (Drug)

Isovue 370 75mL

Active Comparator

Isovue 370 75mL injected 100 kVp 240 mAs

干预措施: Isovue (Drug)

结局指标

主要结局

Radiation Dose

时间窗: 30 minutes

次要结局

  • Signal to Noise Ratio(30 minutes)
  • Hounsfield Unit Attenuation Values(30 minutes)
  • Variation in Contrast for the Entire Vascular System (coV)(30 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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