跳至主要内容
临床试验/NCT01373944
NCT01373944已完成不适用

Rapid-Acquisition Low-Dosimetry Tc-99m Stress-Only Myocardial Perfusion SPECT on the Spectrum Dynamics System: Comparison of Efficiency and Outcomes With Stress-Only Anger SPECT

Aspire Foundation3 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
3
主要终点
Diagnostic Failure

研究概览

简要总结

The purpose of this study is to compare clinical efficiency and patient outcomes using ultra low-dose stress only Tc-99m and solid-state SPECT versus traditional Anger SPECT.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

入选标准

  • BMI < 35 kg/m2
  • LVEF > 40%
  • Exercise stress
  • Elective out-patients
  • No known CAD (>50%) by catheterization
  • No history of prior myocardial infarction

排除标准

  • Pacemaker
  • Atrial Fibrillation
  • Frequent PAC's or PVC's
  • Inability to achieve at least 6 minutes

结局指标

主要结局

Diagnostic Failure

时间窗: 30 days

Diagnostic failure is defined by a composite of need for additional downstream testing (anger SPECT, MPI PET, stress echocardiography or coronary CT angiography) within 30 days or a coronary angiogram with no stenoses greater than or equal to 50% severity using quantitative coronary angiography.

次要结局

  • Necessity to proceed to a rest image(30 days)
  • Necessity for additional downstream testing(30 days)
  • Coronary Angiography(60 to 90 days)
  • Determine optimal performance of the Spectrum Dynamics camera system for stress only imaging(60 to 90 days)

研究者

申办方类型
Other

研究点 (3)

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