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临床试验/NCT00610766
NCT00610766已完成不适用

International PRospective Multicenter Study On RadiaTion Dose Estimates Of Coronary CT AngIOgraphy IN Daily Practice

Deutsches Herzzentrum Muenchen1 个研究点 分布在 1 个国家目标入组 1,965 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,965
试验地点
1
主要终点
Radiation dose estimates of coronary MSCT angiography in daily practice

研究概览

简要总结

Estimation of radiation dose of coronary multislice computed tomography (MSCT) angiography in daily practice in an international, multicenter and vendor-independent trial.

详细描述

Prospective analysis of cardiac CT angiographies enrolled over 1 month

Collection of 1 axial data set and the "patient dose protocol" (including kV, mAs, CTDI, DLP, etc.) on a CD

Dose estimation in dose/cm with the use of a method proposed by the European Working Group for Guidelines on Quality Criteria in CT.

Assessment of diagnostic, qualitative image quality on a per-vessel basis by the participating study sites and in randomly selected cases by the primary study investigators (approximately 5-10% of patients to "spot check" interobserver variability of image quality assessments)

Assessment of image quality with the use of quantitative parameters including image noise, signal-to-noise and contrast-to-noise ratios

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • assessment of coronary arteries
  • acute chest pain or "triple rule out"
  • evaluation after PCI (stents)
  • evaluation of bypass grafts
  • before or after EP study
  • cardiac anomalies

排除标准

  • pregnancy
  • contraindications against contrast media

结局指标

主要结局

Radiation dose estimates of coronary MSCT angiography in daily practice

时间窗: 1 month

次要结局

  • Comparison of dose estimates between 16-slice, 64-slice, DSCT and other CT systems(1 month)
  • Frequency of dose-saving algorithm's use (e.g.: ECG-dose pulsing / Care Dose 4D / 100kv(1 month)
  • Assessment of potentials for additional dose savings (e.g. entire scan length; the distance between scan start to begin of coronary arteries and distance end of coronary arteries to end of scan)(1 month)

研究者

发起方
Deutsches Herzzentrum Muenchen
申办方类型
Other

研究点 (1)

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