Familiarization and Safety Study of PB127 Ultrasound Contrast Agent
A Familiarization and Safety Study of Myocardial Perfusion Contrast Echocardiography With PB127 Ultrasound Contrast Agent in Patients With Suspected Obstructive Coronary Artery Disease
1 other identifier
interventional
150
1 country
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 coronary-artery-disease
Started Feb 2002
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 4, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedJuly 3, 2008
January 1, 2008
1.6 years
January 4, 2008
July 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Technical adequacy and diagnostic quality of PB127 images
24 hours
Secondary Outcomes (1)
Compliance with image acquisition and Pb127 administration procedures
24 hours
Interventions
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
Eligibility Criteria
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
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Point Biomedicallead
Study Sites (34)
Michael Morgan, MD
Phoenix, Arizona, 85018, United States
Heartcare, P.C.
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alexander Ehlgen, MD, PhD
POINT Biomedical Corp.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 4, 2008
First Posted
January 16, 2008
Study Start
February 1, 2002
Primary Completion
September 1, 2003
Study Completion
September 1, 2003
Last Updated
July 3, 2008
Record last verified: 2008-01