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
This trial is to compare PB127 echocardiography to other heart imaging studies.
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 | 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. |
Not provided
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
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 |
|---|---|---|---|---|---|---|
| Michael Morgan, MD | Phoenix | Arizona | 85018 | United States | ||
| Long Beach VA Medical Center Cardiology Division |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 28 days |
| 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 |
| Washington Hospital Center Cardiovascular Research Institute | Washington D.C. | District of Columbia | 20010 | United States |
| The Center for Cardiovascular Studies Kramer & Crouse Cardiology | Shawnee Mission | Kansas | 66204 | United States |
| New England Medical Center | Boston | Massachusetts | 02111 | United States |
| St. Louis University Medical Center | St Louis | Missouri | 63110 | United States |
| The Cleveland Clinic Foundation Department of Cardiology | Cleveland | Ohio | 44195 | United States |
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States |
| University of Pittsburgh Cardiovascular Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Texas Health Sciences Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Harborview Medical Center Department of Cardiology | Seattle | Washington | 98104 | 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