Acquiring Consensus for Contrast Echocardiography System Settings - ACCESS Study

Launched by ACUSPHERE · Apr 29, 2008

Keywords

ClinConnect Summary

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) voluntee...

Gender

ALL

Eligibility criteria

• 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 criteria include: participation in an investigational drug/device study within 30 days prior to dosing (90 days for UK sites), participation in a previous clinical trial of AI-700, non-seasonal asthma within the past 3 years or recent seasonal asthma requiring prescription medication, frequent (\>5/min) premature ventricular or atrial contractions (PVC, PAC), and any ≥2nd AV block, bundle branch block (BBB), or rhythm abnormality.
• • Stable cardiac patients in Cohorts A or B who have had any of the following conditions will be excluded from the study: any clinically unstable condition or major surgery within 30 days prior to Screening/Baseline (including but not limited to severe arterial hypertension, pulmonary hypertension, or any increase in pulmonary pressures due to increased pulmonary resistance, hypotension, bradycardia, tachycardia, unstable angina); cerebrovascular accident or transient ischemic attack within 90 days prior to dosing; congestive heart failure graded as New York Heart Association Class 3 or 4 within 90 days prior to dosing; significant left main CAD (≥50% stenosis); moderate to severe chronic obstructive pulmonary disease (COPD) within 6 months prior to dosing; or oxygen saturation \<90% at rest; and inadequate image quality on the Qualification Echo. Candidates with clinically significant intra-cardiac shunts or any other cardiovascular structural and/or severe functional abnormalities per the Qualification Echo \[including intra cardiac shunts; uncorrected congenital heart disease (i.e., severe valvular disease; large amount of pericardial effusion\], EF (as estimated from the Qualification Echo) of \<40%; are also not eligible to participate. Subjects who exhibit new or changing ECG abnormalities at any time between Screening and AI-700 dosing will be similarly excluded. Other exclusion criteria include: participation in an investigational drug/device study within 30 days prior to dosing (90 days for UK sites), participation in a previous clinical trial of AI-700, non-seasonal asthma within the past 3 years or recent seasonal asthma requiring prescription medication, organ transplant or end-stage organ failure, and active seizure disorder. Candidates will also be excluded for uncontrolled atrial fibrillation, frequent (\>5/min) PVCs or PACs, history of prolonged QT/QTc (\>500 msec), use of automatic implantable cardioverter/defibrillator, and any ≥2nd AV block, BBB, or rhythm abnormality that has not been evaluated and treated by a specialist or for which current treatment is not adequately effective to the extent that subject safety is assured.