Prognostic Assessment of Contrast Echocardiography (PACE Study)

Coronary Artery Disease Clinical Trial

— PACE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00670332
• Other study ID #: AI-700-36
• Status: Terminated
• Phase: N/A
• First received: April 29, 2008
• Last updated: April 29, 2008
• Start date: July 2007

Study information

• Verified date: April 2008
• Source: Acusphere
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 773
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years
• Eligibility: Eligible patients were enrolled in either AI-700-32 or AI-700-33.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Acusphere	Watertown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Acusphere

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No