EUCTR2012-002678-29-FI进行中（未招募）不适用
A Phase 3, Open-Label, Multicenter Study for the Assessment of Myocardial Perfusion using Positron Emission Tomography (PET) Imaging of Flurpiridaz F 18 Injection in Patients with Suspected or Known Coronary Artery Disease (CAD) - None
antheus Medical Imaging, Inc.0 个研究点目标入组 672 人开始时间: 2012年12月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 672
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men and women =18 years of age.
- •2. Have been scheduled via written documentation to undergo CC at the time of enrollment, or have undergone prior CC without intervention (being either positive or negative for the presence of CAD).
- •3. Have undergone a clinically-indicated SPECT which meets all study-specified imaging and stress testing criteria, or the patient is willing to undergo SPECT MPI for the purposes of the clinical study.
- •4. Be capable of undergoing exercise or pharmacologic stress as described in protocol.
- •5. Have provided Informed Consent (IC) prior to undergoing any study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 372
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •1. Female patients who are pregnant or lactating. (All women of child bearing potential [WOCBP] must have a negative serum pregnancy test at screening and within 36 hours prior to start of investigational product administration [predose] regardless of contraceptive use history).
- •2. Women of child-bearing potential are excluded unless they:
- •a. are post-menopausal defined as amenorrhea = 24 consecutive months
- •b. have undergone successful surgical sterilization or
- •c. have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 3 months prior to flurpiridaz F 18 injection dose administration and be willing to continue using the same method for the duration of the study.
- •3. Current illness or pathology that poses a significant safety risk for the patient to undergo investigational product administration and/or cardiac stress testing.Such as:
- •a. uncontrolled symptomatic or New York Heart Association Class III or IV congestive heart failure within 48 hours prior to screening or inability to lie flat for the duration of imaging.
- •b. symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease without suspected or known CAD
- •4. Arterial hypertension or arterial hypotension on 2 consecutive readings within 1 hour prior to flurpiridaz F 18 administration.
- •5.Patients who are clinically incapable of tolerating a stress test as a result of their coronary status. Patients with unstable cardiovascular status excluded from enrollment are :
- •a. myocardial infarction or unstable angina pectoris within 6 months prior to dose administration of flurpiridaz F 18 injection
- •b. transient ischemic attack (TIA) or stroke within 3 months prior to dose administration of flurpiridaz F 18 injection
- •c. clinically significant congenital heart defects.
- •d. current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
- •e. acute pulmonary embolus or pulmonary infarction
- •f. acute myocarditis or pericarditis
- •g. acute aortic dissection
- •6. History of CABG surgery
- •7. PCI within 6 months prior to administration of flurpiridaz F 18 injection
- •8. Current non-ischemic (dilated, hypertrophic, or restrictive) cardiomyopathy that has contraindications to stress testing and/or without known or suspected CAD
- •9. Currently scheduled for a heart transplant or has a history of heart transplantation
- •10. Any major surgery within 4 weeks prior to screening
- •11. Any major surgery planned within 14-17 days following the 2-week telephone follow-up assessment (with the exception of scheduled CABG or other surgical treatment of the underlying cardiovascular disease) (Note: Patients undergoing noninvasive or superficial surgery with a mortality rate of <1% are considered low risk and are NOT excluded from this study.)
- •12. Participation in any investigational study (including drug, device, or placebo studies) within 30 days prior to screening or 2 weeks past any BMS747158-302 study-related procedures
- •13. Participation in any prior study with flurpiridaz F 18 injection
- •14. Prisoners or those who are subject to compulsory detention or involuntary incarceration for treatment of either a psychiatric or physical illness (eg, infectious disease)
- •15. Known or suspected severe or acute hepatic failure or under evaluation for liver transplantation
- •16. Known severe renal disease (glomerular filtration rate [GFR] < 29 mL/min/1.73 m2) or undergoing renal dialysis
研究者
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