NCT00487903终止2 期
A Phase 2 Trial of PB127 Myocardial Perfusion Echocardiography to Evaluate and Optimize Additional Ultrasound Imaging Systems
Point Biomedical6 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Determination of optimal machine settings and imaging parameters for myocardial perfusion for a variety of ultrasound imaging systems to be used in upcoming clinical trials
研究概览
简要总结
The purpose of this clinical trial is to evaluate various commercially available ultrasound systems and to identify imaging parameters to be used with these systems (along with the contrast agent PB127) as well as to further evaluate 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
- •1. Men and women
- •Normal volunteers (18 30 years old), with no history of CAD
- •Patients (≥ 18 years old) with known or suspected CAD, scheduled for or undergone clinically indicated coronary angiography 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
- •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 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
Determination of optimal machine settings and imaging parameters for myocardial perfusion for a variety of ultrasound imaging systems to be used in upcoming clinical trials
时间窗: 24 hours
次要结局
未报告次要终点
研究者
研究点 (6)
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