Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the dose of PB127 for detection and/or exclusion of coronary artery disease when used with cardiac ultrasound. This study also evaluates the safety of PB127.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PB127 for Injectable Suspension | Drug | Stages 1 & 2 0.009 - 0.204 mg/kg continuous IV during rest and stress conditions. Infusion rate of 50 - 125 mL/hr will be adjusted for image quality and diagnostic quality. Infusion limited to 60 minutes or less. Stage 3 - will utilize infusion rate and dose established in Stages 1 & 2. 0.062 mg/kg continuous IV infusion at 150 mL/hr during rest and 100 mL/hr during stress conditions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To identify the minimum effective dose of PB127 | 24 hours | |
| To identify the optimal stress infusion rate of PB127 | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the efficacy of PB127 MPE using the dose and stress infusion rate identified in Stages 1 and 2 | 24 hours | |
| To evaluate the safety of PB127 | 24 hours |
Not provided
Inclusion Criteria:
Stages 1 and 2
Stage 3
Men and women with known or suspected CAD
Ages 18 years and older
Scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following Study Day 1
Scheduled for or undergone SPECT 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:
Use of caffeine or xanthine containing products within the 24 hours prior to PB127 administration on Study Day 1 (Stages 2 and 3)
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 or major surgery 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
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexander Ehlgen, MD, PhD | POINT Biomedical Corp. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach VA Medical Center Cardiology Division | Long Beach | California | 90822 | United States | ||
| University of California San Diego Division of Cardiology |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| San Diego |
| California |
| 92103 |
| United States |
| Alfieri Cardiology | Newark | Delaware | 19713 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Midwest Cardiology Associates | Overland Park | Kansas | 66209 | 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 |
| Cardiovascular Consultants | Kansas City | Missouri | 64111 | United States |
| St. Louis University Medical Center | St Louis | Missouri | 63110 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States |
| University of Pittsburgh Cardiovascular Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| Seton Healthcare Network Brackenridge Hospital | Austin | Texas | 78701 | United States |
| Austin Heart | Austin | Texas | 78705 | 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 |
| 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 |
Not provided
Not provided