NCT02855528已完成不适用
Ultra Low-dose Coronary Artery Calcium Scoring Using Tin Filtration With Dual-source CT
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Reduction in radiation dose using the new tin-filter system
研究概览
简要总结
The aim of this study is to prospectively investigate the diagnostic performance and potential radiation dose reduction in coronary artery calcium scoring using the new tin filter system of the 3rd generation DSCT scanner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- 是
入选标准
- •Subject must be between 19-90 years of age.
- •Subject must have been referred for a clinically indicated coronary artery calcium scan and/or coronary CT angiography or TRO scan with coronary artery calcium scoring.
- •Subject must provide written informed consent prior to any study-related procedures being performed.
- •Subject must be willing to comply with all clinical study procedures.
排除标准
- •Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
- •By testing (urine BHCG) within 24 hours before scan, or
- •By surgical sterilization, or
- •Post menopausal, with minimum one (1) year history without menses.
- •Subject has an acute psychiatric disorder or is cognitively impaired.
- •Subject is using or is dependent on substances of abuse.
- •Subject is unwilling to comply with the requirements of the protocol.
- •Subject is in acute unstable condition.
研究组 & 干预措施
Reduction of radiation dose and diagnostic accuracy
Experimental
Reduction of radiation dose during coronary artery calcium scoring with the use of a tin filter system.
干预措施: Tin Filter (Device)
结局指标
主要结局
Reduction in radiation dose using the new tin-filter system
时间窗: 2 years
Diagnostic accuracy of novel ultralow-dose non-enhanced coronary artery calcium scoring performed with the new tin filter system.
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (2)
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