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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Eligible patients were enrolled in either AI-700-32 or AI-700-33.
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This observational study will enroll up to 773 patients who participated in either AI-700-32 or AI-700-33 and who were evaluated with AI-700 contrast ECHO at rest and at pharmacologic-induced stress. Approximately 28 international study centers will participate. At the time of AI-700 contrast ECHO (defined as the index date), the patients were to have had a recent history of chest pain and were to meet all eligibility criteria. Chest pain (angina) was defined as either:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acusphere | Watertown | Massachusetts | 02472 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |