A Phase 3, Open Label, Multicenter Study for the Assessment of Myocardial Perfusion Using Positron Emission Tomography (PET) Imaging of Flurpiridaz F18 Injection in Patients With Suspected or Known Coronary Artery Disease (CAD)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography
研究概览
简要总结
The study will evaluate the use of Flurpiridaz F18 injection in patients with CAD to determine if the study drug in PET imaging is better than SPECT imaging currently used for this purpose.
详细描述
The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz F18 Injection MPI in comparison with SPECT MPI in patients with known or suspected CAD. Six hundred and seventy-two evaluable patients will be enrolled and will undergo SPECT MPI and Flurpiridaz F18 PET MPI. Patients will be considered for enrollment if they are scheduled to undergo or have undergone prior ICA without intervention (being either positive or negative for CAD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 否
入选标准
- •Invasive Coronary Angiography Men or Women age 18 or older - see protocol for additional details
排除标准
- •Women who are pregnant, lactating, or of child bearing potential who are not practicing birth control Unstable cardiac status History of coronary artery bypass graft History of PCI within the past six months See protocol for additional details
研究组 & 干预措施
Flurpiridaz F18
Open-label study of a single injection of flurpiridaz F18 for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary cathertization
干预措施: Flurpiridaz F18 (Drug)
结局指标
主要结局
Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography
时间窗: 12 months
次要结局
- Diagnositic performance evaluation of multivessel disease (PETvsSPECT)(12 months)
- Detection of CAD in subgroups: pharm stress, females and BMI>/=30(12 months)
- Diagnostic performance evaluation of CAD (PETVsSPECT)(12 months)
- Image quality of rest and stress (PETvsSPECT)(12 months)
- Diagnostic certainty evaluation of rest and stress (PETvsSPECT)(12 months)
- Evaluation of reversible defect size of rest and stress (PETvsSPECT)(12 months)
- Safety evaluation of flurpiridaz F 18 will include monitoring the number participants with adverse events (AEs), medication errors, treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs).(12 months)