Prognostic Assessment of Contrast Echocardiography (PACE Study)
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.
Coronary Artery Disease
Acusphere has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Time Perspective: Retrospective|
|Official Title:||Prognostic Assessment of Contrast Echocardiography (PACE Study): An Observational Follow-up Study of Patients With Chest Pain Evaluated With AI-700 Contrast Echocardiography|
- The primary outcome variable is the time to first occurrence of the composite outcome (death or confirmed non fatal MI). [ Time Frame: The time between AI 700 ECHO and outcomes data collection will be ≥12 months with an expected average follow-up period of 24 months ] [ Designated as safety issue: No ]
- Certain secondary analyses will include revascularizations and CHF. [ Time Frame: The time between AI 700 ECHO and outcomes data collection will be ≥12 months with an expected average follow-up period of 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
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.