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
- 已完成
- 入组人数
- 795
- 试验地点
- 81
- 主要终点
- Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity
研究概览
简要总结
The primary objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to single photon emission computed tomography (SPECT) MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a documented history of Myocardial Infarction (MI).
详细描述
The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz F18 Injection MPI against SPECT MPI in patients screened for CAD as determined by ICA. Six hundred and eighty 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 percutaneous coronary intervention 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 dose of Flurpiridaz F18 injection for PET MPI compared to a single dose of 99mTc sestamibi or tetrofosmin for SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
干预措施: Flurpiridaz F18 (Drug)
Flurpiridaz F18
Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to a single dose of 99mTc sestamibi or tetrofosmin for SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
干预措施: 99mTechnicium (sestamibi or tetrofosmin) (Drug)
结局指标
主要结局
Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity
时间窗: 60 days
Diagnostic efficacy of one day rest and stress flurpiridaz F 18 PET MPI sensitivity versus SPECT MPI sensitivity in the detection of coronary artery disease (CAD) by majority rule using invasive coronary angiography as the truth standard,
Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity
时间窗: 60 days
Diagnostic efficacy of flurpiridaz PET MPI specificity versus SPECT MPI specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard
次要结局
- Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.(60 days)
- Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.(60 days)
- Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).(60 days)
- Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).(60 days)
- Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).(60 days)
- Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good(60 days)
- Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good(60 days)
- Image Quality of Rest and Stress (PET vs SPECT).(60 days)
- Diagnostic Certainty in PET MPI and SPECT MPI(60 days)