Familiarization and Safety Study of PB127 Ultrasound Contrast Agent
NCT ID: NCT00594698
Last Updated: 2008-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
150 participants
INTERVENTIONAL
2002-02-28
2003-09-30
Brief Summary
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Detailed Description
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1. To train potential Phase 3 investigational sites in the preparation and andministration of PB127
2. To train potential Phase 3 investigational sites in the acquisition of adequate images
3. To collect additional safety information regarding intravenous administration of PB127
4. To obtain a larger sample of images obtained with the Acuson Sequoia ultrasound system.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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PB127 for injectable suspension
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Scheduled for stress echocardiography, SPECT nuclear imaging and/or coronary angiography within the two weeks prior to or following Study Day 1
3. Adequate visualization of all myocardial segments in at least one imaging plane during screening non-contrast echocardiogram
Exclusion Criteria
2. Known hypersensitivity or known contraindication to
1. Dipyridamole
2. Other ultrasound contrast agents
3. Blood, blood products, albumin, egg, or protein
3. Use of caffeine or xanthine containing products within the 24 hours prior to PB127 MPE
4. Frequent (\> 60/hour) or symptomatic ventricular ectopics at baseline
5. Atrial fibrillation
6. Permanent pacemaker or defibrillator
7. History of:
1. Complex ventricular arrhythmia
2. Chronic hepatitis
3. 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
4. Chronic obstructive pulmonary disease (COPD) that, in the opinion of the Investigator, was significant enough to contraindicate dipyridamole
5. Bronchospastic airway disease that, in the opinion of the Investigator, was significant enough to contraindicate dipyridamole
6. Coronary artery bypass graft (CABG) within the 7 days prior to Study Day 1
7. Heart transplant
8. Q wave myocardial infarction within the 7 days prior to Study Day 1
9. Cardiac intervention or surgery within the 7 days prior to Study Day 1
8. Hypertension (systolic blood pressure \[SBP\] \>200 mmHg and diastolic blood pressure \[DBP\] \>110 mmHg)
9. Hypotension (SBP \<90 mmHg) documented within the 24 hours prior to Study Day 1
10. Significant valvular disease
1. Severe aortic stenosis (\>100 mmHg peak transvalvar gradient or \<0.6 cm2 estimated valve area)
2. Severe mitral regurgitation (usual clinical criteria plus or minus any of the following: proximal isovelocity surface area \[PISA\] \>1 cm2, forward transmitral gradient of \>2 m/sec, unexplained systolic flow reversal or blunting in the pulmonary veins)
3. Severe mitral stenosis (\<1.0 cm2 estimated valve area)
11. Congestive heart failure (New York Heart Association \[NYHA\] Class IV); NYHA classes are defined in Appendix D of the protocol (see Appendix 16.1.1)
12. Pulmonary edema within the 7 days prior to Study Day 1
13. Resting oxygen saturation of \< 90%
14. Pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of \>50 mmHg by echo or catheter criteria on Study Day 1
15. Unstable angina, Canadian Cardiovascular Society (CCS) Class IV severity, with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin; CCS grading criteria are provided in Appendix E of the protocol (see Appendix 16.1.1)
16. Second degree heart block or greater
17. Use of intravenous or intracoronary contrast agent within the 24 hours prior to Study Day 1
18. Medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives, ie, drug dependence, psychiatric disorder, dementia, or other reasons for expected poor compliance with the Investigator's instructions; medical conditions, associated illness, or extenuating circumstances that made it unlikely that a patient can complete the clinical trial or follow-up evaluations
18 Years
ALL
No
Sponsors
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Point Biomedical
INDUSTRY
Responsible Party
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POINT Biomedical Corp.
Principal Investigators
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Alexander Ehlgen, MD, PhD
Role: STUDY_DIRECTOR
POINT Biomedical Corp.
Locations
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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
Dallas VA Medical Center
Dallas, Texas, United States
Presbyterian Hospital of Dallas
Dallas, Texas, United States
Methodist DeBakery Heart Center Cardiovascular Imaging Institute
Houston, Texas, United States
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Harborview Medical Center Department of Cardiology
Seattle, Washington, United States
Inland Cardiology
Spokane, Washington, United States
Northwest Cardiovascular Research Institute Spokane Cardiology
Spokane, Washington, United States
Countries
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Other Identifiers
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127-005
Identifier Type: -
Identifier Source: org_study_id