Safety and Efficacy Study of PB127 Ultrasound Contrast Agent for Diagnosis of Coronary Artery Disease

Stopped early · Phase 3

Conditions studied: Coronary Artery Disease

In brief

The purpose of this study is to determine if the use of PB127 with cardiac ultrasound assists in the diagnosis or exclusion of coronary artery disease.

Key facts

Study ID

NCT00584896

Run by

Point Biomedical

People needed

1000

Starts

2007-10-01

Expected to finish

2008-07-01

Last updated by the study team

2008-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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, or protein
• Use of caffeine or xanthine containing products within the 24 hours prior to Study Day 1
• Previous exposure to PB127 Ultrasound Contrast Agent
• Major surgery within 7 days prior to Study Day 1 (requiring general anesthesia and/or overnight stay)
• Heart transplant or history of CABG
• Known hemodynamically significant or symptomatic right-to-left shunt (including shunts that are associated with prior TIAs or strokes)
• Recent history of sustained ventricular tachycardia
• Pacemaker or defibrillator
• Unstable cardiac status
• Unstable angina grade CCS Class IV severity (any physical activity causes limiting symptoms; symptoms may be present at rest in a patient with prior exertional angina) with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin
• Decompensated heart failure
• Second-degree or greater heart block, sick sinus syndrome
• Frequent (>60/hour) or symptomatic ventricular ectopics at baseline
• Hypertension (SBP >200 and/or DBP >110 mmHg on two consecutive readings within one hour of PB127 MPE)
• Hypotension (SBP <90 mmHg)
• Severe aortic stenosis (>40 mmHg mean gradient or <0.6 cm2/m2 valve area index)
• Pulmonary edema within the 7 days prior to Study Day 1
• Resting oxygen saturation of less than 90% on room air
• Myocardial infarction or cerebral vascular accident / transient ischemic attack within the 28 days prior to Study Day 1
• 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

Where it is running

• University of Arizona Saver Heart Clinic — Tucson, Arizona, United States
• Cardiovascular Associates of the Peninsula — Burlingame, California, United States
• Long Beach VA Medical Center Cardiology Division — Long Beach, California, United States
• Cedars Sinai Medical Center Division of Cardiology — Los Angeles, California, United States
• Sutter Roseville Medical Center — Roseville, California, United States
• University of California San Diego Division of Cardiology — San Diego, California, United States
• San Francisco VA Medical Center NCIRE — San Francisco, California, United States
• Connecticut Clinical Research — Bridgeport, Connecticut, United States
• Alfieri Cardiology — Newark, Delaware, United States
• Washington Hospital Center Cardiovascular Research Institute — Washington D.C., District of Columbia, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Midwest Cardiology Associates — Overland Park, Kansas, United States
• The Center for Cardiovascular Studies Kramer & Crouse Cardiology — Shawnee Mission, Kansas, United States
• Western Baptist Hospital The Heart Group — Paducah, Kentucky, United States
• Androscoggin Cardiovascular Associates — Auburn, Maine, United States
• Maine Cardiology Associates — South Portland, Maine, United States
• Brigham & Women's Hosptial — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mayo Clinic Department of Cardiology — Rochester, Minnesota, United States
• Cardiovascular Consultants — Kansas City, Missouri, United States
• St. Louis University Medical Center — St Louis, Missouri, United States
• North Shore University Hospital — Manhasset, New York, United States
• St. Luke's Roosevelt Hospital Echocardiography Lab — New York, New York, United States
• Stonybrook University Medical Center — Stony Brook, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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