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Sponsored by: |
Point Biomedical |
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Information provided by: | Point Biomedical |
ClinicalTrials.gov Identifier: | NCT00595673 |
This trial is to compare PB127 echocardiography to other heart imaging studies.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Drug: PB127 for injectable suspension |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Single Group Assignment, Safety/Efficacy Study |
Enrollment: | 428 |
Study Start Date: | July 2002 |
Study Completion Date: | October 2003 |
Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Stratum 1:
Stratum 2:
Stratum 3:
Exclusion Criteria:
Known hypersensitivity or known contraindication to:
Unstable cardiac status
Liver disease (i.e., current or previous hepatic viral infection, chronic hepatitis) characterized by one or more of the following
United States, Arizona | |
Heartcare, P.C. | |
Scottsdale, Arizona, United States, 85258 | |
Mayo Clinic Scottsdale | |
Scottsdale, Arizona, United States, 85259 | |
United States, California | |
Stanford University Medical Center | |
Stanford, California, United States, 94305 | |
University of California San Francisco | |
San Francisco, California, United States, 94143 | |
United States, Indiana | |
Krannert Institute of Cardiology | |
Indianapolis, Indiana, United States, 46202 | |
United States, Kansas | |
The Center for Cardiovascular Studies Kramer & Crouse Cardiology | |
Shawnee Mission, Kansas, United States, 66204 | |
United States, Maine | |
Androscoggin Cardiovascular Associates | |
Auburn, Maine, United States, 04210 | |
Maine Cardiology Associates | |
South Portland, Maine, United States, 04106 | |
United States, Missouri | |
Cardiovascular Consultants | |
Kansas City, Missouri, United States, 64111 | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
Mount Sinai Hospital | |
New York, New York, United States, 10029 | |
St. Luke's Roosevelt Hospital Echocardiography Lab | |
New York, New York, United States, 10025 | |
United States, Ohio | |
MidWest Cardiologist Research | |
Columbus, Ohio, United States, 43214 | |
United States, Oregon | |
Endovascular Research, LLC | |
Eugene, Oregon, United States, 97401 | |
United States, Texas | |
Austin Heart | |
Austin, Texas, United States, 78705 | |
Methodist DeBakery Heart Center Cardiovascular Imaging Institute | |
Houston, Texas, United States, 77030 | |
Presbyterian Hospital of Dallas | |
Dallas, Texas, United States, 75231 | |
United States, Virginia | |
University of Virginia Health System | |
Charlottesville, Virginia, United States, 22908 | |
United States, Washington | |
Inland Cardiology | |
Spokane, Washington, United States, 99204 |
Study Director: | Alexander Ehlgen, MD, PhD | POINT Biomedical Corp. |
Responsible Party: | POINT Biomedical Corp ( Tom Ottoboni/Chief Operating Officer ) |
Study ID Numbers: | 127-007 |
Study First Received: | January 7, 2008 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00595673 |
Health Authority: | United States: Food and Drug Administration |
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