NCT00584896终止3 期
A Phase 3 Clinical Trial to Assess Perfusion and Obstruction Identified by Non-Invasive Technology Using PB127 Ultrasound Contrast Agent in Patients With Suspected Obstructive Coronary Artery Disease II
Point Biomedical77 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2007年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 1,000
- 试验地点
- 77
- 主要终点
- To evaluate the diagnostic performance of PB127 MPE for the detection and/or exclusion of significant obstructive coronary artery disease as defined by qualitative coronary angiography or qualifying clinical outcome
研究概览
简要总结
The purpose of this study is to determine if the use of PB127 with cardiac ultrasound assists in the diagnosis or exclusion of coronary artery disease.
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
- •18 years old or older and able to provide written informed consent;
- •All subjects must be scheduled for or have undergone SPECT within 28 days prior to or following Study Day 1
- •Subjects with very low/low pre-test probability of coronary artery disease must consent to participate in the extension trial 127-014-A
- •Subjects with very low/low pre-test probability of coronary artery disease must not have a current diagnosis of obstructive CAD on angiogram or prior MI
- •Subjects with very low/low pre-test probability of coronary artery disease with a current diagnosis of obstructive CAD on angiogram or prior MI may be enrolled into Stratum 2
- •Subjects with intermediate or high pre-test probability of coronary artery disease must be scheduled for coronary angiography within the 28 days following Study Day 1
- •Sinus rhythm at the time of the study procedure
- •Adequate visualization of myocardial segments
- •Appropriate candidate for stress testing according to ACC/AHA Guidelines for Exercise Testing
排除标准
- •Women who are pregnant or lactating
- •Known hypersensitivity or known contraindication to:
- •Dipyridamole
- •Ultrasound contrast agents (including PB127 and excipients)
- •Blood, blood products, albumin, egg, or protein
- •Use of caffeine or xanthine containing products within the 24 hours prior to Study Day 1
- •Previous exposure to PB127 Ultrasound Contrast Agent
- •Major surgery within 7 days prior to Study Day 1 (requiring general anesthesia and/or overnight stay)
- •Heart transplant or history of CABG
- •Known hemodynamically significant or symptomatic right-to-left shunt (including shunts that are associated with prior TIAs or strokes)
- •Recent history of sustained ventricular tachycardia
- •Pacemaker or defibrillator
- •Unstable cardiac status
- •Unstable angina grade CCS Class IV severity (any physical activity causes limiting symptoms; symptoms may be present at rest in a patient with prior exertional angina) with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin
- •Decompensated heart failure
- •Second-degree or greater heart block, sick sinus syndrome
- •Frequent (>60/hour) or symptomatic ventricular ectopics at baseline
- •Hypertension (SBP >200 and/or DBP >110 mmHg on two consecutive readings within one hour of PB127 MPE)
- •Hypotension (SBP <90 mmHg)
- •Severe aortic stenosis (>40 mmHg mean gradient or <0.6 cm2/m2 valve area index)
- •Pulmonary edema within the 7 days prior to Study Day 1
- •Resting oxygen saturation of less than 90% on room air
- •Myocardial infarction or cerebral vascular accident / transient ischemic attack within the 28 days prior to Study Day 1
- •Chronic Obstructive Pulmonary Disease (COPD) or bronchospastic airway disease, which in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
- •Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg
- •Liver disease characterized by one or more of the following
- •Current jaundice
- •Elevated bilirubin > upper limit of normal
- •Currently elevated hepatic enzymes > 2X upper limit of normal
- •Current or previous hepatic viral infection (not including hepatitis A)
- •Chronic hepatitis
- •Medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives (i.e., drug dependence, psychiatric disorder, dementia, or associated illness); extenuating circumstances or medical conditions that make it unlikely that a patient can complete the clinical trial or follow up evaluations; or other reasons for expected poor compliance with the clinical investigator's instructions.
结局指标
主要结局
To evaluate the diagnostic performance of PB127 MPE for the detection and/or exclusion of significant obstructive coronary artery disease as defined by qualitative coronary angiography or qualifying clinical outcome
时间窗: 72 hours, 6 months
次要结局
- To compare the diagnostic performance of PB127 MPE to SPECT for the detection and/or exclusion of significant obstructive coronary artery disease.(72 hours, 6 months)
- To assess the concordance of PB127 MPE with SPECT in the differentiation of defect type (fixed versus reversible) in patients with significant obstructive CAD.(72 hours, 6 months)
- To evaluate the diagnostic performance characteristics of PB127 MPE for identifying the location of significant obstructive CAD as defined by quantitative coronary angiography(72 hours)
- To assess the change in diagnostic certainty when PB127 MPE and relevant clinical information are combined over relevant clinical information alone.(72 hours, 6 months)
研究者
研究点 (77)
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