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临床试验/NCT02458352
NCT02458352已完成不适用

Usefulness of Ultra Low Dose Cardiac CT for Coronary Calcium Scoring and for Attenuation Correction of SPECT

University of Zurich2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2015年11月最近更新:
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
105
试验地点
2
主要终点
Agreement and Correlation of Coronary Artery Calcium Score Obtained From Ultra-low-dose and Standard CT

研究概览

简要总结

The aim of the study is to compare the CACS obtained from standard dose CT to the CACS obtained from ultra-low-dose scans. Additionally, the usefulness of ultra-low-dose CT for AC of myocardial perfusion SPECT will be assessed.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients referred for myocardial perfusion SPECT
  • Male and Female subjects ≥18 years of age,
  • Written informed consent

排除标准

  • Pregnancy or breast-feeding
  • CACS of 0 after inclusion of 10 patients with CACS 0
  • Stents or implanted cardiac devices (valves, pace makers, ICD)
  • Coronary artery bypass grafts

研究组 & 干预措施

Standard dose CT, Ultra-low dose CT

Other

Standard dose non-contrast enhanced CT (clinically indicated) and Ultra low dose non-contrast enhanced CT (as part of the trial)

干预措施: Ultra low dose non-contrast enhanced CT (Device)

Standard dose CT, Ultra-low dose CT

Other

Standard dose non-contrast enhanced CT (clinically indicated) and Ultra low dose non-contrast enhanced CT (as part of the trial)

干预措施: Standard dose non-contrast enhanced CT (Device)

结局指标

主要结局

Agreement and Correlation of Coronary Artery Calcium Score Obtained From Ultra-low-dose and Standard CT

时间窗: 1 days

CAC and BA limits of agreement between coronary artery calcium score obtained from ultra-low-dose and standard CT. Coronary artery calcium (CAC) is a measure for quantification of coronary artery calcification based on non-contrast enhanced CT, ranging from 0 (no calcifications) to infinite. It is an arbitrary unit. Increasing CAC means higher amounts of coronary artery calcifications and is associated with worse prognosis. Bland-Altman (BA) analysis is a statistical method to compare two modalities or techniques assessing the same measure. Limits of agreement is defined as +/- twice the standard deviation of the differences between the reference method and the new modality/technique. Broader limits of agreement mean less accurate results obtained by the new modality/techniqe, while a 0 BA limit of agreement would theoretically reflect perfect agreement.

Intra-class Correlation Coefficient Between Segmental Relative Tracer Uptake From SPECT Datasets Reconstructed With AC Maps Based on Ultra-Low-Dose and Standard Dose CT

时间窗: 1 day

For every patient, the CT images from 120 and 70 kVp-CT scans were used to create CTAC maps which were then used to reconstruct SPECT images, displayed as a 17-segment model polar plot with normalized percent tracer uptake given for every segment. Intra-class correlation was then applied to compare segmental relative tracer uptake. Analysis and the resulting correlation coefficient of 0.987 basically demonstrates interchangeability between the two datasets.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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