Safety and Efficacy Study of PB127 Ultrasound Contrast Agent for Diagnosis of Coronary Artery Disease

Exclusion Criteria

• •1. Women who are pregnant or lactating
• •2. Known hypersensitivity or known contraindication to:
• •1. Dipyridamole
• •2. Ultrasound contrast agents (including PB127 and excipients)
• •3. Blood, blood products, albumin, egg, or protein
• •3. Use of caffeine or xanthine containing products within the 24 hours prior to Study Day 1
• •4. Previous exposure to PB127 Ultrasound Contrast Agent
• •5. Major surgery within 7 days prior to Study Day 1 (requiring general anesthesia and/or overnight stay)
• •6. Heart transplant or history of CABG
• •7. Known hemodynamically significant or symptomatic right-to-left shunt (including shunts that are associated with prior TIAs or strokes)
• •8. Recent history of sustained ventricular tachycardia
• •9. Pacemaker or defibrillator
• •10. Unstable cardiac status
• •1. Unstable angina grade CCS Class IV severity (any physical activity causes limiting symptoms; symptoms may be present at rest in a patient with prior exertional angina) with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin
• •2. Decompensated heart failure
• •3. Second-degree or greater heart block, sick sinus syndrome
• •4. Frequent (\>60/hour) or symptomatic ventricular ectopics at baseline
• •5. Hypertension (SBP \>200 and/or DBP \>110 mmHg on two consecutive readings within one hour of PB127 MPE)
• •6. Hypotension (SBP \<90 mmHg)
• •7. Severe aortic stenosis (\>40 mmHg mean gradient or \<0.6 cm2/m2 valve area index)
• •8. Pulmonary edema within the 7 days prior to Study Day 1
• •9. Resting oxygen saturation of less than 90% on room air
• •11. Myocardial infarction or cerebral vascular accident / transient ischemic attack within the 28 days prior to Study Day 1
• •12. Chronic Obstructive Pulmonary Disease (COPD) or bronchospastic airway disease, which in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
• •13. Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of \>50 mmHg
• •14. Liver disease characterized by one or more of the following
• •1. Current jaundice
• •2. Elevated bilirubin \> upper limit of normal
• •3. Currently elevated hepatic enzymes \> 2X upper limit of normal
• •4. Current or previous hepatic viral infection (not including hepatitis A)
• •5. Chronic hepatitis
• •15. Medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives (i.e., drug dependence, psychiatric disorder, dementia, or associated illness); extenuating circumstances or medical conditions that make it unlikely that a patient can complete the clinical trial or follow up evaluations; or other reasons for expected poor compliance with the clinical investigator's instructions.