Prognostic Assessment of Contrast Echocardiography (PACE Study)
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT00670332
- Lead Sponsor
- Acusphere
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 773
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome variable is the time to first occurrence of the composite outcome (death or confirmed non fatal MI). The time between AI 700 ECHO and outcomes data collection will be ≥12 months with an expected average follow-up period of 24 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Acusphere
🇺🇸Watertown, Massachusetts, United States