Acquiring Consensus for Contrast Echocardiography System Settings - ACCESS Study (NCT00669851) | Clinical Trial Compass
CompletedPhase 3
Acquiring Consensus for Contrast Echocardiography System Settings - ACCESS Study
United States39 participantsStarted 2006-11
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 exclusion c…
What they're measuring
1
Image quality of echocardiographic data collected via several ultrasound imaging platforms
2
For Cohort B, the duration of MCE following the first 0.04 mL/kg dose of AI-700
3
Safety of AI-700 administered IV to healthy volunteers and suspected CAD patients