Evaluation of Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress BR1-142

Inclusion Criteria:

Provides written Informed Consent and is willing to comply with protocol requirements;

- Is at least 18 years of age;

- Has suspected or known CAD and is scheduled to undergo coronary angiography within 6
months after the LUMASON DSE.

- Has undergone a previous echocardiography prior to enrollment; resulting in suboptimal
unenhanced images at rest, defined as ≥ 2 suboptimal adjacent segments in any apical
view.

Exclusion Criteria:

- Is 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;

- Has any known hypersensitivity to 1 or more ingredients of LUMASON (sulfur
hexafluoride or to any components of LUMASON);

- Has any known hypersensitivity to dobutamine;

- Has an ongoing or recent (within the last 30 days) acute myocardial infarction;

- Has known right-to-left, bidirectional or transient cardiac shunt (ruled out with
agitated saline study performed before administration of LUMASON);

- Has electrolyte (especially potassium and magnesium) abnormalities;

- Has 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;

- Has uncontrolled cardiac arrhythmias;

- Has significant disturbance in conduction;

- Has hypertrophic subaortic stenosis;

- Has 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;

- Has been treated with any other contrast agent either intravascularly or orally within
48 hours of the first LUMASON administration;

- Has 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 have not reached targeted heart
rate with peak dobutamine infusion, subjects with the following will be excluded:

- Glaucoma;

- Pyloric stenosis;

- Prostatic hypertrophy.