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临床试验/NCT00587730
NCT00587730终止2 期

Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 608 人开始时间: 2001年7月最近更新:
适应症

试验速览

阶段
2 期
状态
终止
发起方
Mayo Clinic
入组人数
608
试验地点
2
主要终点
The overall comparisons of the agreement between conventional SPECT imaging and the GE Hawkeye system will be completed using McNemar's test.

研究概览

简要总结

The accuracy of stress single photon emission computed tomography (SPECT) is limited by imaging artifacts, many of which are caused by soft tissue attenuation. A recent multicenter study performed by our laboratory comparing 7 commercially available attenuation correction (AC) camera systems in a cardiac phantom showed the best performance with the GE Hawkeye (a hybrid gamma camera-CT scanner) and the University of Michigan M-step (unique feature a camera orbit of 360˚ versus the usual 180˚) systems. In this study we will combine the strengths of these two systems (GE Hawkeye AC system and 360˚ camera orbit) to test the accuracy of this imaging system in a population of 400 consecutive patients undergoing clinically indicated stress SPECT. These patients will undergo SPECT imaging both with conventional methodology and the GE Hawkeye system. The conventional study will be interpreted and reported in the usual clinical fashion. The GE Hawkeye images will be interpreted independently by 2 observers blinded to the results of conventional imaging and will not be reported clinically. The primary study hypothesis is that AC will substantially reduce attenuation artifacts (mild fixed defects) without reducing the accuracy of either normal studies or myocardial infarction (MI). Clinical data and noninvasive test results (history of MI, electrocardiogram, and gated wall motion) will be used to distinguish defects which represent attenuation (false-positive) versus those due to MI (true-positive).

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 to the Charlton Nuclear Cardiology Laboratory for stress Tc-99m sestamibi SPECT
  • Exclusion criteria:
  • Prior PTCA or CABG
  • Left bundle branch block (LBBB) or paced ventricular rhythm
  • Clinically significant valvular heart disease
  • Hypertrophic or idiopathic dilated cardiomyopathy
  • Atrial fibrillation or frequent atrial or ventricular ectopy (defined as >20% ectopic beats
  • History of MI
  • ECG evidence of MI
  • Chest circumference >55 inches

排除标准

  • 未提供

结局指标

主要结局

The overall comparisons of the agreement between conventional SPECT imaging and the GE Hawkeye system will be completed using McNemar's test.

时间窗: Measured/Compared at time of each scan.

次要结局

  • Comparisons of categorical factors between the 2 tests will also be completed using McNemar's test, continuous factors will be completed using a paired t-test if the differences are normally distributed.(Measured/Compared at time of study)

研究者

发起方
Mayo Clinic
申办方类型
Other

研究点 (2)

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