Evaluation and Optimization of PB127 Myocardial Perfusion Echocardiography on Ultrasound Systems

Study Overview
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Brief Summary
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The purpose of this clinical trial is to evaluate various commercially available ultrasound systems and to identify imaging parameters to be used with these systems (along with the contrast agent PB127) as well as to further evaluate the safety of PB127.

Official Title
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A Phase 2 Trial of PB127 Myocardial Perfusion Echocardiography to Evaluate and Optimize Additional Ultrasound Imaging Systems

Conditions
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Coronary Artery Disease, Healthy

Intervention / Treatment
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* Drug: PB127 for Injectable Suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Men and women Normal volunteers (18 30 years old), with no history of CAD Patients (≥ 18 years old) with known or suspected CAD, scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following Study Day 1 Exclusion Criteria: Unable to provide written informed consent Women who are pregnant or lactating Known hypersensitivity or known contraindication to: Dipyridamole Ultrasound contrast agents (including PB127 and excipients) Blood, blood products, albumin, egg whites, or protein Use of caffeine or xanthine containing products within the 24 hours prior to PB127 administration on Study Day 1 Previous exposure to PB127 Inadequate echocardiographic windows Heart transplant Known right to left shunt, including atrial septal defect History of CABG Current uncontrolled ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter Pacemaker or defibrillator Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of IV nitroglycerin Second degree or greater heart block Hypertension (SPB >200 and/or DBP >110 mmHg on two consecutive readings within 1 hour prior to PB127 administration) Hypotension (SPB <90 mmHg on two consecutive readings within 1 hour prior to PB127 administration) Severe aortic stenosis (>100 mmHg peak transvalvar gradient or <0.6 cm2 estimated valve area) Pulmonary edema within the 7 days prior to Study Day 1 Resting oxygen saturation of less than 90% Q wave MI within the 7 days prior to Study Day 1 PTCA within the 28 days prior to Study Day 1 Chronic obstructive pulmonary disease or bronchospastic airway disease which, in the opinion of the Investigator, is significant enough to contraindicate dipyridamole Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg Liver disease, characterized by or including one or more of the following Elevated total bilirubin >upper limit of normal Currently elevated hepatic enzymes >3X upper limit of normal 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PB127 for Injectable Suspension|0.062 mg/kg continuous IV (100-250 mL/hr) during echocardiogram, single dose, infusion not to exceed 60 minutes.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of optimal machine settings and imaging parameters for myocardial perfusion for a variety of ultrasound imaging systems to be used in upcoming clinical trials |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast, Coronary Artery Disease, Echocardiogram, Perfusion, Ultrasound, Normal volunteers