Prognostic Assessment of Contrast Echocardiography (PACE Study)

NCT00670332 | Terminated

• 1 other identifier: AI-700-36
• Study Type: observational
• Target: 773
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Acusphere: lead

Study Sites (1)

Acusphere

Watertown, Massachusetts, 02472, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 1, 2008
• Study Start: July 1, 2007
• Last Updated: May 1, 2008

Record last verified: 2008-04

Locations

US (1)