Evaluation and Optimization of PB127 Myocardial Perfusion Echocardiography on Ultrasound Systems

Exclusion Criteria

• •1. Unable to provide written informed consent
• •2. Women who are pregnant or lactating
• •3. Known hypersensitivity or known contraindication to:
• •1. Dipyridamole
• •2. Ultrasound contrast agents (including PB127 and excipients)
• •3. Blood, blood products, albumin, egg whites, or protein
• •4. Use of caffeine or xanthine containing products within the 24 hours prior to PB127 administration on Study Day 1
• •5. Previous exposure to PB127
• •6. Inadequate echocardiographic windows
• •7. Heart transplant
• •8. Known right to left shunt, including atrial septal defect
• •9. History of CABG
• •10. Current uncontrolled ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter
• •11. Pacemaker or defibrillator
• •12. Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of IV nitroglycerin
• •13. Second degree or greater heart block
• •14. Hypertension (SPB \>200 and/or DBP \>110 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
• •15. Hypotension (SPB \<90 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
• •16. Severe aortic stenosis (\>100 mmHg peak transvalvar gradient or \<0.6 cm2 estimated valve area)
• •17. Pulmonary edema within the 7 days prior to Study Day 1
• •18. Resting oxygen saturation of less than 90%
• •19. Q wave MI within the 7 days prior to Study Day 1
• •20. PTCA within the 28 days prior to Study Day 1
• •21. Chronic obstructive pulmonary disease or bronchospastic airway disease which, in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
• •22. Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of \>50 mmHg
• •23. Liver disease, characterized by or including one or more of the following
• •1. Elevated total bilirubin \>upper limit of normal
• •2. Currently elevated hepatic enzymes \>3X upper limit of normal
• •24. 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