Ischemic Memory Imaging With MCE
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Detection of Ischemia
研究概览
简要总结
The overall aim of this study is to determine whether non-invasive imaging with myocardial contrast echocardiography using can provide information on the presence and spatial extent of recent myocardial ischemia by non-invasive echocardiographic imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal control individuals
排除标准
- •History of cardiovascular disease (coronary artery disease, MI, peripheral artery disease)
- •allergy to eggs or ultrasound contrast agents
- •known or detected right to left shunt
- •presence of a wall motion abnormality
- •pregnancy
- •Inclusion Criteria:
- •Patients with diagnosis of acute coronary syndrome with either unstable angina or non-ST-elevation MI
- •Referred for primary percutaneous intervention
- •At least 1 high risk features (ST changes, positive troponin, wall motion abnormality)
- •Exclusion Criteria:
- •allergy to eggs or ultrasound contrast agents
- •hemodynamic instability or shock
- •known or detected right to left shunt
- •pregnancy
- •multivessel CAD requiring multivessel PCI
研究组 & 干预措施
Normal controls
Normal controls who will undergo dose-ranging studies to determine the optimal dose of phosphatidylserine-containing microbubbles that does not produce delayed myocardial opacification on myocardial contrast echocardiography (MCE).
干预措施: Sonazoid (Drug)
Patients with ACS
Subjects with ACS who have undergone primary percutaneous intervention in whom MCE with phosphatidylserine-containing microbubbles will be performed to determine whether the risk area can be detected and spatially defined.
干预措施: Sonazoid (Drug)
结局指标
主要结局
Detection of Ischemia
时间窗: 1 year
Dose optimization
时间窗: 3 months
Dose ranging in normal controls to define highest dose of ultrasound contrast agent that does not produce delayed opacification from myocardial retention
次要结局
未报告次要终点
研究者
Jonathan R. Lindner, MD
Professor
Oregon Health and Science University