NCT00584818已完成2 期
A Phase 2 Dose-Finding Clinical Trial of CARDIOsphere® (PB127) in Normal Volunteers and in Patients With Known or Suspected Coronary Artery Disease
Point Biomedical32 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2006年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 32
- 主要终点
- To identify the minimum effective dose of PB127
研究概览
简要总结
The purpose of this study is to determine the dose of PB127 for detection and/or exclusion of coronary artery disease when used with cardiac ultrasound. This study also evaluates the safety of PB127.
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
- 是
入选标准
- •Stages 1 and 2
- •Men and women
- •Normal volunteers
- •No history (or suspicion) of CAD
- •Men and women with known or suspected CAD
- •Ages 18 years and older
- •Scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following Study Day 1
- •Coronary angiography within 28 days prior to Study Day 1 and/or SPECT must have been non-interventional
- •Coronary angiography images available in digital format (non cine) for transmission to core laboratory
- •Scheduled for or undergone SPECT within 28 days prior to or following Study Day 1
排除标准
- •Unable to provide written informed consent
- •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 whites, or protein
- •Use of caffeine or xanthine containing products within the 24 hours prior to PB127 administration on Study Day 1 (Stages 2 and 3)
- •Previous exposure to PB127
- •Inadequate echocardiographic windows
- •Heart transplant
- •Known right to left shunt, including atrial septal defect
- •History of CABG
- •Current uncontrolled ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter
- •Pacemaker or defibrillator
- •Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of IV nitroglycerin
- •Second degree or greater heart block
- •Hypertension (SPB >200 and/or DBP >110 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
- •Hypotension (SPB <90 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
- •Severe aortic stenosis (>100 mmHg peak transvalvar gradient or <0.6 cm2 estimated valve area)
- •Pulmonary edema within the 7 days prior to Study Day 1
- •Resting oxygen saturation of less than 90%
- •Q wave MI or major surgery within the 7 days prior to Study Day 1
- •PTCA within the 28 days prior to Study Day 1
- •Chronic obstructive pulmonary disease 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 or including one or more of the following
- •Elevated total bilirubin > upper limit of normal
- •Currently elevated hepatic enzymes >3X upper limit of normal
- •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 identify the minimum effective dose of PB127
时间窗: 24 hours
To identify the optimal stress infusion rate of PB127
时间窗: 24 hours
次要结局
- To assess the efficacy of PB127 MPE using the dose and stress infusion rate identified in Stages 1 and 2(24 hours)
- To evaluate the safety of PB127(24 hours)
研究者
研究点 (32)
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