Safety and Efficacy Study of PB127 Ultrasound Contrast Agent in Patients With Suspected Coronary Artery Disease 007
NCT ID: NCT00595673
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
428 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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Heartcare, P.C.
Scottsdale, Arizona, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
University of California San Francisco
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Krannert Institute of Cardiology
Indianapolis, Indiana, United States
The Center for Cardiovascular Studies Kramer & Crouse Cardiology
Shawnee Mission, Kansas, United States
Androscoggin Cardiovascular Associates
Auburn, Maine, United States
Maine Cardiology Associates
South Portland, Maine, United States
Cardiovascular Consultants
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
St. Luke's Roosevelt Hospital Echocardiography Lab
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
MidWest Cardiologist Research
Columbus, Ohio, United States
Endovascular Research, LLC
Eugene, Oregon, United States
Austin Heart
Austin, Texas, United States
Presbyterian Hospital of Dallas
Dallas, Texas, United States
Methodist DeBakery Heart Center Cardiovascular Imaging Institute
Houston, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Inland Cardiology
Spokane, Washington, United States
Countries
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Other Identifiers
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127-007
Identifier Type: -
Identifier Source: org_study_id