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临床试验/NCT02985931
NCT02985931已完成不适用

Single-scan Rest/Stress Imaging With Cadmium Zinc Telluride-based SPECT for Coronary Flow Quantification

Chang Gung Memorial Hospital0 个研究点目标入组 30 人开始时间: 2012年5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
30
主要终点
Correlation between SPECT- and MRI-measured flow values

研究概览

简要总结

The investigators aim to address this issue with novel image quantification methods using CZT-based SPECT, which is capable of dynamic data acquisition and therefore feasible for the quantification of the coronary flow. The investigators will use kinetic modeling techniques to design a study that allows the absolute flow quantification. To make this study practical, the investigators will develop a protocol that includes the acquisition of both the rest and stress scan within the same scan that is shorter than 30 minutes. The SPECT-measured flow will be validated against the flow measured with cardiac MRI scans. Patients with high CAD risk will be recruited for the clinical trial. Data from these human subjects will be used for determination of the performance of the developed algorithm. With the proposed rapid scan with absolute quantification capabilities, the investigators expect to increase the diagnosis accuracy while maintaining the patient throughput.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with high possibility of coronary artery disease after being evaluated by a cardiologist.
  • > 20 years old.
  • Not under infection or other conditions inappropriate for being recruited.
  • Without myocardial infarction within one week.
  • With stable blood pressure.
  • Subjects with normal kidney functions and without allergic reactions to MRI contrast agents.

排除标准

  • Subjects who cannot take a SPECT scan or do not agree to sign the informed consent.
  • Pregnant subjects or subjects who are currently breast-feeding.
  • Those currently under radiation therapies.
  • Patients with pleural effusion.
  • Patients who are allergic to SPECT tracers.
  • Patients with serious psychological disorders.
  • Patients with asthma.
  • Patients with stroke within a week.
  • Patients with AV block.
  • Patients with sinus syndrome.
  • Subjects who are currently under other clinical trials.
  • Subjects with poor kidney functions who are inappropriate for MRI contrast agents.
  • Subjects with pacemakers.
  • Subjects with Claustrophobia.
  • Subjects who cannot hold breath for cardiac MRI studies.

结局指标

主要结局

Correlation between SPECT- and MRI-measured flow values

时间窗: through study completion, an average of 3 year

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tzu-Chen Yen

Professor

Chang Gung Memorial Hospital

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