Familiarization and Safety Study of PB127 Ultrasound Contrast Agent

Completed · Phase 2/Phase 3

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00594698

Run by

Point Biomedical

People needed

150

Starts

2002-02-01

Expected to finish

2003-09-01

Last updated by the study team

2008-07-03

Who can join

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

You may qualify if…

• Able to provide written informed consent
• Scheduled for stress echocardiography, SPECT nuclear imaging and/or coronary angiography within the two weeks prior to or following Study Day 1
• Adequate visualization of all myocardial segments in at least one imaging plane during screening non-contrast echocardiogram

You may not qualify if…

• Women who were pregnant or lactating
• Known hypersensitivity or known contraindication to
• Dipyridamole
• Other ultrasound contrast agents
• Blood, blood products, albumin, egg, or protein
• 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:
• current jaundice
• elevated bilirubin > upper limit of normal
• currently elevated hepatic enzymes > 2X upper limit of normal
• current or previous hepatic viral infection
• 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

Where it is running

• Michael Morgan, MD — Phoenix, Arizona, United States
• Heartcare, P.C. — Scottsdale, Arizona, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• Long Beach VA Medical Center Cardiology Division — Long Beach, 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
• University of California San Francisco — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Washington Hospital Center Cardiovascular Research Institute — Washington D.C., District of Columbia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Krannert Institute of Cardiology — Indianapolis, Indiana, United States
• The Center for Cardiovascular Studies Kramer and Crouse Cardiology — Shawnee Mission, Kansas, United States
• Androscoggin Cardiovascular Associates — Auburn, Maine, United States
• Maine Cardiology Associates — South Portland, Maine, United States
• New England Medical Center — Boston, Massachusetts, United States
• Cardiovascular Consultants — Kansas City, Missouri, United States
• St. Louis University Medical Center — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Mount Sinai Hospital — New York, New York, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• MidWest Cardiologist Research — Columbus, Ohio, United States
• Endovascular Research, LLC — Eugene, Oregon, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• University of Pittsburgh Cardiovascular Institute — Pittsburgh, Pennsylvania, United States
• Austin Heart — Austin, Texas, United States

Full record on ClinicalTrials.gov

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