Coronary Artery Disease
Conditions
Keywords
coronary artery disease, echocardiography, cardiac imaging, heart disease, ultrasound contrast agent, myocardial contrast enhancement, myocardial perfusion
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.
Interventions
DRUGAI-700
Sponsors
Acusphere
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Exclusion criteria
* Healthy volunteers in Cohort A who have or have had any of the following conditions will be excluded from the study: clinically significant intra-cardiac shunts or any other cardiovascular structural and/or severe functional abnormalities on the Qualification Echo, unless deemed not clinically relevant by the Investigator and subsequently approved by the Sponsor; ejection fraction (EF, estimated from the Qualification Echo) that is ≤55% (outside normal range), history or clinical manifestations of significant mental illness or significant pulmonary, hematological, renal, hepatic, central nervous, cardiovascular, genitourinary, or gastrointestinal disorders, or diabetes; history of any major surgical procedure within 90 days of Screening/Baseline; body mass index (BMI) \>35; sitting systolic blood pressure \<90 mmHg or \>150 mmHg, diastolic blood pressure \<50 mmHg or \>95 mmHg, or a pulse rate \<45 bpm or \>90 bpm; oxygen saturation \<92% at rest; and inadequate image quality on the Qualification Echo. Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed