Acquiring Consensus for Contrast Echocardiography System Settings - ACCESS Study
Tracking Information | |
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First Received Date ICMJE | April 29, 2008 |
Last Updated Date | April 29, 2008 |
Start Date ICMJE | November 2006 |
Primary Completion Date | |
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current |
Change History | No Changes Posted |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Acquiring Consensus for Contrast Echocardiography System Settings - ACCESS Study |
Official Title ICMJE | 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 |
Brief Summary | 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 | 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 ICMJE | Interventional |
Study Phase | Phase 3 |
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
Condition ICMJE | Coronary Artery Disease |
Intervention ICMJE | Drug: AI-700 |
Study Arm (s) | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 39 |
Completion Date | March 2007 |
Primary Completion Date | |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years to 80 Years |
Accepts Healthy Volunteers | Yes |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States |
Administrative Information | |
NCT Number ICMJE | NCT00669851 |
Other Study ID Numbers ICMJE | AI-700-34 |
Has Data Monitoring Committee | |
Responsible Party | |
Study Sponsor ICMJE | Acusphere |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Acusphere |
Verification Date | April 2008 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |