Prognostic Assessment of Contrast Echocardiography (PACE Study)

Prognostic Assessment of Contrast Echocardiography (PACE Study): An Observational Follow-up Study of Patients With Chest Pain Evaluated With AI-700 Contrast Echocardiography

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00670332

Acronym

PACE

Enrollment

773

Registered

2008-05-01

Start date

2007-07-31

Completion date

Unknown

Last updated

2008-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

coronary artery disease, echocardiography, cardiac imaging, heart disease, ultrasound contrast agent, prognosis

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.

Interventions

None listed

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Eligible patients were enrolled in either AI-700-32 or AI-700-33.

Design outcomes

Primary

Measure	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

Secondary

Measure	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

Countries

United States

Outcome results