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The purpose of this study is to evaluate preparation and administration of PB127, echocardiographic images obtained during PB127 administration, and evaluate the safety of PB127.
The primary objectives of this clinical trial are:
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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 5% Dextrose for Injection in glass bottles, to be administered as a single continuous infusion during image acquisition. Infusion time not to exceed 60 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical adequacy and diagnostic quality of PB127 images | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance with image acquisition and Pb127 administration procedures | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
Women who were pregnant or lactating
Known hypersensitivity or known contraindication to
Use of caffeine or xanthine containing products within the 24 hours prior to PB127 MPE
Frequent (> 60/hour) or symptomatic ventricular ectopics at baseline
Atrial fibrillation
Permanent pacemaker or defibrillator
History of:
Complex ventricular arrhythmia
Chronic hepatitis
Liver disease characterized by one or more of the following:
Chronic obstructive pulmonary disease (COPD) that, in the opinion of the Investigator, was significant enough to contraindicate dipyridamole
Bronchospastic airway disease that, in the opinion of the Investigator, was significant enough to contraindicate dipyridamole
Coronary artery bypass graft (CABG) within the 7 days prior to Study Day 1
Heart transplant
Q wave myocardial infarction within the 7 days prior to Study Day 1
Cardiac intervention or surgery within the 7 days prior to Study Day 1
Hypertension (systolic blood pressure [SBP] >200 mmHg and diastolic blood pressure [DBP] >110 mmHg)
Hypotension (SBP <90 mmHg) documented within the 24 hours prior to Study Day 1
Significant valvular disease
Congestive heart failure (New York Heart Association [NYHA] Class IV); NYHA classes are defined in Appendix D of the protocol (see Appendix 16.1.1)
Pulmonary edema within the 7 days prior to Study Day 1
Resting oxygen saturation of < 90%
Pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg by echo or catheter criteria on Study Day 1
Unstable angina, Canadian Cardiovascular Society (CCS) Class IV severity, with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin; CCS grading criteria are provided in Appendix E of the protocol (see Appendix 16.1.1)
Second degree heart block or greater
Use of intravenous or intracoronary contrast agent within the 24 hours prior to Study Day 1
Medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives, ie, drug dependence, psychiatric disorder, dementia, or other reasons for expected poor compliance with the Investigator's instructions; medical conditions, associated illness, or extenuating circumstances that made it unlikely that a patient can complete the clinical trial or follow-up evaluations
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Ehlgen, MD, PhD | POINT Biomedical Corp. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael Morgan, MD | Phoenix | Arizona | 85018 | United States | ||
| Heartcare, P.C. |
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| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259 | United States |
| Long Beach VA Medical Center Cardiology Division | Long Beach | California | 90822 | United States |
| University of California San Diego Division of Cardiology | San Diego | California | 92103 | United States |
| San Francisco VA Medical Center NCIRE | San Francisco | California | 94121 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| Washington Hospital Center Cardiovascular Research Institute | Washington D.C. | District of Columbia | 20010 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Krannert Institute of Cardiology | Indianapolis | Indiana | 46202 | United States |
| The Center for Cardiovascular Studies Kramer and 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 |
| New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Cardiovascular Consultants | Kansas City | Missouri | 64111 | United States |
| St. Louis University Medical Center | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| MidWest Cardiologist Research | Columbus | Ohio | 43214 | United States |
| Endovascular Research, LLC | Eugene | Oregon | 97401 | United States |
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States |
| University of Pittsburgh Cardiovascular Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| Austin Heart | Austin | Texas | 78705 | United States |
| Dallas VA Medical Center | Dallas | Texas | 75216 | 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 Texas Health Sciences Center at San Antonio | San Antonio | Texas | 78229 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Harborview Medical Center Department of Cardiology | Seattle | Washington | 98104 | United States |
| Inland Cardiology | Spokane | Washington | 99204 | United States |
| Northwest Cardiovascular Research Institute Spokane Cardiology | Spokane | Washington | 99204 | United States |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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