Prognostic Assessment of Contrast Echocardiography (PACE Study): An Observational Follow-up Study of Patients With Chest Pain Evaluated With AI-700 Contrast Echocardiography
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 773
- 试验地点
- 1
- 主要终点
- The primary outcome variable is the time to first occurrence of the composite outcome (death or confirmed non fatal MI).
研究概览
简要总结
This study will demonstrate whether patients with prognostically-significant myocardial abnormalities detected with AI-700 contrast ECHO have a rate of cardiac death or MI that is higher than that of patients with normal AI-700 contrast ECHO.
详细描述
This observational study will investigate the ability of AI-700 contrast ECHO to predict risk of future cardiovascular events occurring in patients who had a recent history of chest pain at the time of ECHO evaluation. Eligible patients were enrolled in either AI-700-32 or AI-700-33, which are completed Phase 3 international, multicenter, open-label, dual-injection studies of the myocardial imaging capabilities and safety of AI-700 administered intravenously in patients with chest pain. In the course of these Phase 3 studies, patients were evaluated with AI-700 contrast ECHO. In addition, eligible patients were to have had an evaluable pharmacologic stress-induced AI-700 ECHO assessment as part of AI-700-32 or AI-700-33.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The primary outcome variable is the time to first occurrence of the composite outcome (death or confirmed non fatal MI).
时间窗: The time between AI 700 ECHO and outcomes data collection will be ≥12 months with an expected average follow-up period of 24 months
次要结局
- Certain secondary analyses will include revascularizations and CHF.(The time between AI 700 ECHO and outcomes data collection will be ≥12 months with an expected average follow-up period of 24 months)