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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014