Prognostic Assessment of Contrast Echocardiography (PACE Study)
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Purpose
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.
| Condition |
|---|
|
Coronary Artery Disease |
Acusphere has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
| Study Type: | Observational |
| 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 ]
| Estimated Enrollment: | 773 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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:
- typical chest pain: 1) substernal chest discomfort with a characteristic quality and duration that is 2) provoked by exertion or emotional stress and 3) relieved by rest or nitroglycerin, or
- atypical chest pain (angina) that meets 2 of the 3 typical chest pain characteristics.
Eligible patients were enrolled in either AI-700-32 or AI-700-33.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Johh F. Cavanaugh, Acusphere |
| ClinicalTrials.gov Identifier: | NCT00670332 History of Changes |
| Other Study ID Numbers: | AI-700-36 |
| Study First Received: | April 29, 2008 |
| Last Updated: | April 29, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Acusphere:
|
coronary artery disease echocardiography cardiac imaging |
heart disease ultrasound contrast agent prognosis |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013