Safety and Efficacy Study of PB127 Ultrasound Contrast Agent in Patients With Suspected Coronary Artery Disease
NCT ID: NCT00595244
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
PHASE3
456 participants
INTERVENTIONAL
2002-07-31
2003-10-31
Brief Summary
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Detailed Description
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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 Dextrose in Water 5% in glass bottles to be infused at 250 mL/hour until stead state achieve, 150 mL/hour during rest image acquisition, and 100-150 mL/hr during stress image acquistion. Single IV infusion, not to exceed 60 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Able to provide written informed consent
2. Low (less than 10%) pre-test probability of CAD (Appendix D)
3. Scheduled for clinically indicated stress echocardiography or stress SPECT within the 14 days prior to or following Study Day 1 (prior to coronary angiography) or coronary angiography within the 7 days following Study Day 1
4. Technically adequate unreconstructed stress SPECT data or scheduled for clinically indicated stress SPECT within 14 days of Study Day 1 and prior to coronary angiography
5. Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
6. No evidence of a right-to-left shunt during non-contrast echocardiography
Stratum 2:
1. Able to provide written informed consent
2. Intermediate (10% to 90%) pre-test probability of CAD (Appendix D)
3. Scheduled for clinically indicated coronary angiography within the 7 days following Study Day 1
4. Technically adequate unreconstructed stress SPECT data or scheduled for stress SPECT within 14 days of Study Day 1 and prior to coronary angiography
5. Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
6. No evidence of a right-to-left shunt during non-contrast echocardiography
Stratum 3:
1. Able to provide written informed consent
2. High (greater than 90%) pre-test probability of CAD (Appendix D)
3. Scheduled for clinically indicated coronary angiography within the 7 days following Study Day 1
4. Technically adequate unreconstructed stress SPECT data or scheduled for stress SPECT within 14 days of Study Day 1 and prior to coronary angiography
5. Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
6. No evidence of a right-to-left shunt during non-contrast echocardiography
Exclusion Criteria
2. Known hypersensitivity or known contraindication to:
1. Dipyridamole
2. Ultrasound contrast agents (including PB127 and excipients)
3. Blood, blood products, albumin, egg, or protein
3. Use of caffeine or xanthine containing products within the 24 hours prior to PB127 MCE
4. Previous exposure to PB127 Ultrasound Contrast Agent
5. Heart transplant
6. Known right-to-left shunt including atrial septal defect
7. Current or history of uncontrolled ventricular tachycardia
8. Current atrial fibrillation, atrial tachycardia, or atrial flutter
9. Pacemaker or defibrillator
10. Unstable cardiac status
1. Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin (See Appendix F)
2. Second-degree or greater heart block
3. Frequent (\>60/hour) or symptomatic ventricular ectopics at baseline
4. Hypertension (SPB \>200 and/or DBP \>110 mmHg on two consecutive readings within one hour of PB127 MCE)
5. Hypotension (SPB \<90 mmHg)
6. Severe aortic stenosis (\>100 mmHg peak transvalvar gradient or \<0.6 cm2 estimated valve area)
7. Pulmonary edema within the 7 days prior to Study Day 1
8. Resting oxygen saturation of less than 90%
9. Q-wave myocardial infarction within the 7 days prior to Study Day 1
10. PTCA or CABG within the 7 days prior to Study Day 1
11. Chronic Obstructive Pulmonary Disease (COPD) or bronchospastic airway disease which, in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
12. Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of \>50 mmHg
13. Use of intravenous or intracoronary contrast agent other than thallium or technetium within the 24 hours prior to Study Day 1
14. Liver disease (i.e., current or previous hepatic viral infection, chronic hepatitis) characterized by one or more of the following
1. Current jaundice
2. Elevated bilirubin \> upper limit of normal
3. Currently elevated hepatic enzymes \> 2X upper limit of normal
15. Medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives (i.e., drug dependence, psychiatric disorder, dementia, or associated illness), extenuating circumstances, medical conditions that make it unlikely that a patient can complete the clinical trial or follow-up evaluations, or other reasons for expected poor compliance with the Investigator's instructions
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
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
Washington Hospital Center Cardiovascular Research Institute
Washington D.C., District of Columbia, United States
The Center for Cardiovascular Studies Kramer & Crouse Cardiology
Shawnee Mission, Kansas, United States
New England Medical Center
Boston, Massachusetts, United States
St. Louis University Medical Center
St Louis, Missouri, United States
The Cleveland Clinic Foundation Department of Cardiology
Cleveland, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
University of Pittsburgh Cardiovascular Institute
Pittsburgh, Pennsylvania, United States
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Harborview Medical Center Department of Cardiology
Seattle, Washington, United States
Northwest Cardiovascular Research Institute Spokane Cardiology
Spokane, Washington, United States
Countries
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Other Identifiers
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127-006
Identifier Type: -
Identifier Source: org_study_id