Acquiring Consensus for Contrast Echocardiography System Settings

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-03-31

Brief Summary

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This study evaluated and optimized settings for, and evaluated the performance of, AI-700-enhanced echocardiographic imaging on several ultrasound imaging platforms, as well as collected additional safety data for AI-700 in healthy volunteers and stable cardiac patients.

Detailed Description

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Because the quality of AI-700-enhanced images is in part determined by the ultrasound (US) settings selection, the continuing study of different imaging modes and/or techniques is required in order to provide US settings recommendations for the many available systems. Therefore AI-700-enhanced imaging was performed in this study using imaging platforms and modes not previously tested and the AI-700 dose and administration methods employed in previous Phase 3 studies.

Two cohorts of subjects were studied at each site. Enrollment commenced with Cohort A and included normal (healthy) volunteers and stable cardiac patients. Settings optimization was performed in Cohort A using a single platform and real-time imaging. If the Sponsor agreed that the images and settings acquired in Cohort A were acceptable, the site was authorized to begin enrollment in Cohort B using the platform and settings that were defined in Cohort A. Authorized sites enrolled stable cardiac patients in Cohort B; no healthy volunteers were studied. For Cohort B subjects, the first 0.04 mL/kg dose of AI 700 was used to evaluate real-time imaging with the settings defined in Cohort A. The second dose of AI-700 for Cohort B subjects may have been used to confirm the data obtained with the first dose, or to explore imaging in a second mode (e.g. 3D/4D) and/or using real-time, high mechanical index triggered imaging on a second platform.

Conditions

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Coronary Artery Disease

Keywords

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coronary artery disease echocardiography cardiac imaging heart disease ultrasound contrast agent myocardial contrast enhancement myocardial perfusion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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AI-700

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* For Cohort A, men and non-pregnant/non-lactating women in good health who are 18 to 70 years of age and who have a low chance of CAD will be enrolled.
* For Cohort B, men and non-pregnant/non-lactating women in good health who are 18-70 years of age who have had a prior MI and/or coronary artery revascularization intervention \>90 days before AI-700 administration, without new or recurrent angina will be enrolled.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Locations

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Acusphere, Inc.

Watertown, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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AI-700-34

Identifier Type: -

Identifier Source: org_study_id

Acquiring Consensus for Contrast Echocardiography System Settings - ACCESS Study