A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 730
- 试验地点
- 53
- 主要终点
- Sensitivity and Specificity of Flurpiridaz (18F) Injection Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) in the Detection of Significant Coronary Artery Disease (CAD) as Defined by Cardiac Catheterization
研究概览
简要总结
This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected 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
- •The participant was a man or woman ≥18 years of age.
- •The participant had read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed.
- •At the time of enrolment, the participant had been scheduled via written documentation to undergo an ICA for the assessment of CAD.
- •The participant had undergone a clinically indicated SPECT OR the participant was willing to undergo SPECT MPI for the purposes of the clinical study.
- •The participant was male or was a nonpregnant, nonlactating female who was either surgically sterile or was post-menopausal.
- •The participant was able and willing to comply with all study procedures as described in the protocol.
排除标准
- •Participants who were pregnant, may possibly be pregnant, or wish (including their partners) to became pregnant during the study period, or were lactating.
- •Participants who were unable to undergo all of the imaging procedures.
- •Participants who had an established diagnosis of CAD as confirmed by any of the following:
- •Previous myocardial infarction (MI);
- •Previous cardiac catheter angiography showing ≥50% stenosis;
- •Previous coronary revascularisation, such as percutaneous coronary intervention (PCI), thrombolysis or coronary artery bypass graft (CABG) placement.
- •Participants incapable of undergoing either exercise or pharmacological cardiac stress testing.
- •Participants who had a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the participant during cardiac stress testing.
- •Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) <50%).
- •Participants scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ICA.
- •Participants undergoing evaluation for heart transplantation or with history of heart transplantation.
- •Participants enrolled in another clinical study within the 30 days prior to being enrolled in this study or scheduled to participate in another clinical study during the 7-day follow-up period of this study.
研究组 & 干预措施
1
Flurpiridaz PET MPI (following off-study SPECT MPI)
干预措施: PET MPI (Drug)
1
Flurpiridaz PET MPI (following off-study SPECT MPI)
干预措施: SPECT MPI (Drug)
1
Flurpiridaz PET MPI (following off-study SPECT MPI)
干预措施: Pharmacological stress agents (Drug)
结局指标
主要结局
Sensitivity and Specificity of Flurpiridaz (18F) Injection Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) in the Detection of Significant Coronary Artery Disease (CAD) as Defined by Cardiac Catheterization
时间窗: Up to 60 days
Sensitivity was defined as true positives (TP)/(TP+false negatives \[FN\]). TP was participants with abnormal PET MPI and disease positive by truth standard and FN was participants with normal PET MPI and disease positive by truth standard. Specificity defined as true negatives (TN)/(TN+ false positives \[FP\]). TN was participants with normal PET MPI and disease negative by truth standard and FP was participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of \>=50 percent (%) in \>=1 coronary artery or major branch of a coronary artery as determined by quantitative coronary angiography (QCA) analysis. Participants were considered to have CAD if QCA revealed \>=50% stenosis of \>=1 major coronary artery or major branch. Sensitivity and specificity were calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers.
次要结局
- Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for All Participants When the Diagnosis of CAD by ICA Was the Standard of Truth(Up to 60 days)
- Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Female Participants When the Diagnosis of CAD by ICA Was the Standard of Truth(Up to 60 days)
- Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Participants With Body-mass Index (BMI) >=30 Kilograms Per Square Meter (kg/m^2) When the Diagnosis of CAD by ICA Was the Standard of Truth(Up to 60 days)
- Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Diabetic Participants When the Diagnosis of CAD by ICA Was the Standard of Truth(Up to 60 days)