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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Image quality of echocardiographic data collected via several ultrasound imaging platforms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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
次要结局
未报告次要终点