Acquiring Consensus for Contrast Echocardiography System Settings - ACCESS Study
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
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 coronary-artery-disease
Started Nov 2006
Shorter than P25 for phase_3 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 29, 2008
CompletedFirst Posted
Study publicly available on registry
May 1, 2008
CompletedMay 1, 2008
April 1, 2008
April 29, 2008
April 29, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acuspherelead
Study Sites (1)
Acusphere, Inc.
Watertown, Massachusetts, 02472, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 29, 2008
First Posted
May 1, 2008
Study Start
November 1, 2006
Study Completion
March 1, 2007
Last Updated
May 1, 2008
Record last verified: 2008-04