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This trial is to compare PB127 echocardiography to other heart imaging studies.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PB127 for injectable suspension | Drug | 0.175 mg/kg diluted in 150 mL Dextrose in Water 5% in glass bottles to be infused at 250 mL/hour until stead state achieve, 150 mL/hour during rest image acquisition, and 100-150 mL/hr during stress image acquistion. Single IV infusion, not to exceed 60 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the non-inferiority of the diagnostic performance of PB127 MCE versus stress SPECT in the detection and/or exclusion of significant obstructive CAD as defined by QCA or qualifying clinical outcome. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the concordance of PB127 MCE with stress SPECT in differentiating between reversible vs. fixed defects in patients with significant obstructive CAD | 28 days | |
| To compare the diagnostic performance of PB127 MCE with stress SPECT in identifying the location of stenosis as identified by coronary angiography. |
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Inclusion Criteria:
Stratum 1:
Stratum 2:
Stratum 3:
Exclusion Criteria:
Women who are pregnant or lactating
Known hypersensitivity or known contraindication to:
Use of caffeine or xanthine containing products within the 24 hours prior to PB127 MCE
Previous exposure to PB127 Ultrasound Contrast Agent
Heart transplant
Known right-to-left shunt including atrial septal defect
Current or history of uncontrolled ventricular tachycardia
Current atrial fibrillation, atrial tachycardia, or atrial flutter
Pacemaker or defibrillator
Unstable cardiac status
Chronic Obstructive Pulmonary Disease (COPD) 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
Use of intravenous or intracoronary contrast agent other than thallium or technetium within the 24 hours prior to Study Day 1
Liver disease (i.e., current or previous hepatic viral infection, chronic hepatitis) characterized by one or more of the following
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, 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 Investigator's instructions
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Ehlgen, MD, PhD | POINT Biomedical Corp. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heartcare, P.C. | Scottsdale | Arizona | 85258 | United States | ||
| Mayo Clinic Scottsdale |
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| 28 days |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| Krannert Institute of Cardiology | Indianapolis | Indiana | 46202 | United States |
| The Center for Cardiovascular Studies Kramer & Crouse Cardiology | Shawnee Mission | Kansas | 66204 | United States |
| Androscoggin Cardiovascular Associates | Auburn | Maine | 04210 | United States |
| Maine Cardiology Associates | South Portland | Maine | 04106 | United States |
| Cardiovascular Consultants | Kansas City | Missouri | 64111 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| St. Luke's Roosevelt Hospital Echocardiography Lab | New York | New York | 10025 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| MidWest Cardiologist Research | Columbus | Ohio | 43214 | United States |
| Endovascular Research, LLC | Eugene | Oregon | 97401 | United States |
| Austin Heart | Austin | Texas | 78705 | United States |
| Presbyterian Hospital of Dallas | Dallas | Texas | 75231 | United States |
| Methodist DeBakery Heart Center Cardiovascular Imaging Institute | Houston | Texas | 77030 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Inland Cardiology | Spokane | Washington | 99204 | United States |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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