Prognostic Assessment of Contrast Echocardiography (PACE Study)

This study has been terminated.
Sponsor:
Information provided by:
Acusphere
ClinicalTrials.gov Identifier:
NCT00670332
First received: April 29, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Acusphere:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670332

Locations
United States, Massachusetts
Acusphere
Watertown, Massachusetts, United States, 02472
Sponsors and Collaborators
Acusphere
  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 April 22, 2014