Acquiring Consensus for Contrast Echocardiography System Settings - ACCESS Study
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|ClinicalTrials.gov Identifier: NCT00669851|
Recruitment Status : Completed
First Posted : May 1, 2008
Last Update Posted : May 1, 2008
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: AI-700||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, International, Exploratory, Open-Label, Multicenter, Dual-Injection, Echocardiographic Imaging Settings and Safety Study of AI-700 in Normal Volunteers and Stable Cardiac Patients|
|Study Start Date :||November 2006|
|Actual Study Completion Date :||March 2007|
- Image quality of echocardiographic data collected via several ultrasound imaging platforms
- For Cohort B, the duration of MCE following the first 0.04 mL/kg dose of AI-700
- Safety of AI-700 administered IV to healthy volunteers and suspected CAD patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669851
|United States, Massachusetts|
|Watertown, Massachusetts, United States, 02472|