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临床试验/NCT03637231
NCT03637231终止不适用

Ultra-low-dose Coronary Artery Calcium Scoring: Evaluation of Prognostic Performance and Impact of Physiological Factors on Quantification in a Large Population

University of Zurich2 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2018年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
301
试验地点
2
主要终点
Impact of BMI on CAC scores derived from low-dose versus standard-dose CT

研究概览

简要总结

Radiation exposure to patients from CT for CAC scoring has steadily decreased in recent years. This is mainly achieved through lowering tube currents alongside with the introduction of iterative reconstruction algorithms which allow compensating for increased image noise. However, the greatest radiation dose reduction can be obtained by reducing peak tube voltage. Yet lowering peak tube voltage remains challenging because tissue attenuation is closely related to photon energy, thus rendering the established thresholds for calculating CAC scores (i.e. Agatston scores) incomparable if peak tube voltages other than the standard 120 kilovolt peak (kVp) are applied. The investigators have developed novel tube-adapted thresholds for CAC scoring by CT at 80 kVp and 70-kVp tube voltage and have shown that these novel thresholds are valid, yielding results closely comparable to the standard 120-kVp protocol. The present study aims to optimize application of such low-dose scans in a general population through assessment of the impact of physiological patient parameters on image parameters such as image noise which per se may impact the accuracy and feasibility of ultra-low-dose CAC scoring with reduced tube voltage. Furthermore, the prognostic performance of such low-dose CAC scoring will be elucidated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
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 a non-contrast enhanced CT scan for CAC scoring
  • 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 50 patients with CACS 0 (as assessed visually after the first CT scan, prior to performing the 3 additional study scans)
  • History of coronary artery stenting, coronary artery bypass grafting, of implantation of cardiac devices (e.g. valve prosthesis, pacemaker, implantable cardioverter defibrillator etc.)
  • Enrolment of the investigator, his/her family members, employees and other dependent persons

结局指标

主要结局

Impact of BMI on CAC scores derived from low-dose versus standard-dose CT

时间窗: 2 years

Assessment of deviation of CAC scores derived from low-dose CT versus standard-dose CT (i.e. standard of reference) by calculating bias and Bland-Altmann limits of agreement as well as intraclass correlation in different subgroups of patients, stratified by body mass index.

次要结局

  • Prognostic value of CAC scores derived from CT scans with varying tube voltages(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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