NCT00976053已完成4 期
Clinical Effectiveness of Pharmacologic Stress Radionuclide Myocardial Perfusion Imaging as a Guide to Management of Patients With Known CAD: Comparison of Single-Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Diagnostic failure of SPECT vs PET
研究概览
简要总结
The purpose of this study is to compare pharmacologic stress myocardial perfusion PET with pharmacologic stress myocardial perfusion SPECT in a near-simultaneous, head-to-head comparison in the same patient. The investigators hypothesize that pharmacologic stress myocardial perfusion PET will prove superior to pharmacologic stress myocardial perfusion SPECT as a first-line diagnostic test for higher-risk patients with known coronary artery disease (CAD) who present with symptoms consistent with possible worsening of their CAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of coronary artery disease
- •New or worsening symptoms
- •Out-patients and in-hospital patients
排除标准
- •Creatinine above 2.5 mg%
- •PCI within prior 6 months
- •Pregnant females
- •Cardiomyopathy (LVEF below 40%)
- •Significant valvular heart disease
- •Body mass index greater than 38
结局指标
主要结局
Diagnostic failure of SPECT vs PET
时间窗: 60 days
次要结局
- Each of individual components of clinical failure(12 months)
- Relative direct and downstream costs(3 months, 6 months, 12 months)
- Composite of diagnostic or clinical failure(12 months)
- Relative effect on quality of life(3 months, 6 months)
研究者
Timothy M. Bateman
Prinicpal Investigator/Medical Director
Aspire Foundation
研究点 (2)
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