Evaluation of Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress BR1-141

Inclusion Criteria:

• Provided written Informed Consent and was willing to comply with protocolrequirements;
• Was at least 18 years of age;
• Had suspected or known CAD and was scheduled to undergo coronary angiography within 6months after the LUMASON DSE.
• Had undergone a previous echocardiography prior to enrollment; resulting in suboptimalunenhanced images at rest, defined as ≥ 2 suboptimal adjacent segments in any apicalview.

Exclusion Criteria:

• Was a pregnant or lactating female. Excluded the possibility of pregnancy by testingon site at the institution (serum or urine βHCG) within 24 hours prior to the start ofLUMASON 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 (sulfurhexafluoride 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 withagitated 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 diastolicblood 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, includinghypertrophic 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 decreasethe chances of obtaining reliable data, achieving study objectives, or completing thestudy and/or postdose follow-up examinations; In addition, due to the use of Atropine in subjects who had not reached targeted heart ratewith peak dobutamine infusion, subjects with the following were excluded:
• Glaucoma;
• Pyloric stenosis;
• Prostatic hypertrophy.