A Prospective Multicenter Phase III Clinical Evaluation of the Safety and Efficacy of Lumason™/SonoVue® in Subjects Undergoing Pharmacologic Stress Echocardiography With Dobutamine for the Diagnosis of Coronary Artery Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 13
- 主要终点
- Sensitivity and Specificity of Lumason Enhanced Dobutamine Stress Echo (DSE) for Detection or Exclusion of Coronary Artery Disease (CAD)
研究概览
简要总结
The purpose of this study was to assess the safety and efficacy of Lumason-enhanced dobutamine stress echo (DSE) in subjects having a suboptimal left ventricular endocardial border delineation (LV EBD) at rest and who were scheduled for coronary angiography.
详细描述
The study was designed to assess the safety and efficacy of Lumason at improving the visualization of the LV EBD during pharmacologic stress echocardiography examinations and for detection or exclusion of the coronary artery disease (CAD). The study population consisted of adult subjects referred for pharmacological stress echocardiography and with suboptimal image quality during unenhanced ultrasound imaging at rest who had known or suspected CAD. Subjects enrolled in the study represented subjects who could benefit most from CEUS stress echocardiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provided written Informed Consent and comply with protocol requirements;
- •Was at least 18 years of age;
- •Had suspected of having CAD and undergoing coronary angiography within 6 months after the LUMASON DSE.
- •Had undergone a previous echocardiography prior to enrollment; resulting in suboptimal unenhanced images at rest, defined as ≥ 2 suboptimal adjacent segments in any apical view.
排除标准
- •Was a pregnant or lactating female. Exclude the possibility of pregnancy: by testing on site at the institution (serum or urine βHCG) within 24 hours prior to the start of LUMASON administration(s), by surgical history (e.g., tubal ligation or hysterectomy), post menopausal with a minimum 1 year without menses;
- •Had any known hypersensitivity to 1 or more ingredients of LUMASON (sulfur hexafluoride or to any components of LUMASON);
- •Had any known hypersensitivity to dobutamine;
- •Had an ongoing or recent (within the last 30 days) acute myocardial infarction;
- •Had known right-to-left, bidirectional or transient cardiac shunt (ruled out with agitated saline study performed before administration of LUMASON);
- •Had electrolyte (especially potassium and magnesium) abnormalities;
- •Had unstable pulmonary and/or systemic hemodynamic conditions e.g.:
- •decompensated or inadequately controlled congestive heart failure (NYHA Class IV);
- •hypovolemia;
- •uncontrolled hypertension, i.e. resting systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg;
- •unstable angina;
- •acute coronary syndrome;
- •aortic dissection;
- •acute pericarditis,
- •myocarditis, or endocarditis;
- •stenosis of the main left coronary artery;
- •hemodynamically significant outflow obstruction of the left ventricle, including hypertrophic obstructive cardiomyopathy;
- •hemodynamically significant cardiac valvular defect;
- •acute pulmonary embolism;
- •Had uncontrolled cardiac arrhythmias;
- •Had significant disturbance in conduction;
- •Had hypertrophic subaortic stenosis;
- •Had an acute illness (e.g., infections, hyperthyroidism, or severe anemia);
- •Was previously entered into this study or received an investigational compound within 30 days before admission into this study;
- •Had been treated with any other contrast agent either intravascularly or orally within 48 hours of the first LUMASON administration;
- •Had any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or postdose follow-up examinations;
- •In addition, due to the use of Atropine in subjects who had not reached targeted heart rate with peak dobutamine infusion, subjects with the following were excluded:
- •Glaucoma;
- •Pyloric stenosis;
- •Prostatic hypertrophy.
研究组 & 干预措施
Lumason
Lumason (sulfur hexafluoride lipid-type A microspheres) 2 mL IV injection
干预措施: Lumason (Drug)
结局指标
主要结局
Sensitivity and Specificity of Lumason Enhanced Dobutamine Stress Echo (DSE) for Detection or Exclusion of Coronary Artery Disease (CAD)
时间窗: Participants were followed until they had coronary angiography or up to 6 months post dose to collect clinical information on cardiac events if no coronary angiography were performed
The diagnostic performance of the echocardiographic images was compared to the truth standard to determine sensitivity and specificity. A diagnosis of CAD was determined for both the echo images and truth standard (positive diagnosis for CAD is defined as \>/= 50% stenosis of any vessel on coronary angiography or if no coronary angiography was performed the occurence of a cardiac event based on clinical information for up to 6 months post dose; otherwise the diagnosis was negative). Results for sensitivity and specificity are reflected based on difference between contrast enhanced stress echo and unenhanced stress echo. Results for analysis of data based on majority assessment from the three off-site blinded readers are presented. Sensitivity and specificity are the percentages of correctly diagnosed subjects by stress echo over the total positive and negative subjects according to the truth standard respectively.
Reader-Specific Percentages of Participants Identified as Having a Critical Shift From Suboptimal to Optimal Echocardiographic Images
时间窗: Participants were followed until they had coronary angiography or up to 6 months post dose to collect clinical information on cardiac events if no coronary angiography was performed
The percentage of subjects with suboptimal images (defined as \>= 2 adjacent segments with inadequate LV EBD in any of the 3 apical views) at unenhanced stress echo converted to adequate (reduction of suboptimal segments in any of the 3 apical views) at contrast-enhanced stress echo
次要结局
- Number of Participants With Adverse Events(72 hours post dose)
- Change in Total LV EBD(Participants were followed until they had coronary angiography or up to 6 months post dose to collect clinical information on cardiac events if no coronary angiography was performed)