Dose Finding Study of PB127 Ultrasound Contrast Agent in Healthy Volunteers and Patients With Coronary Artery Disease
NCT ID: NCT00584818
Last Updated: 2008-04-25
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
205 participants
INTERVENTIONAL
2006-11-30
2008-03-31
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
Stages 1 \& 2 0.009 - 0.204 mg/kg continuous IV during rest and stress conditions. Infusion rate of 50 - 125 mL/hr will be adjusted for image quality and diagnostic quality. Infusion limited to 60 minutes or less.
Stage 3 - will utilize infusion rate and dose established in Stages 1 \& 2. 0.062 mg/kg continuous IV infusion at 150 mL/hr during rest and 100 mL/hr during stress conditions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Men and women
2. Ages 18 30
3. Normal volunteers
4. No history (or suspicion) of CAD
Stage 3
1. Men and women with known or suspected CAD
2. Ages 18 years and older
3. Scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following Study Day 1
1. Coronary angiography within 28 days prior to Study Day 1 and/or SPECT must have been non-interventional
2. Coronary angiography images available in digital format (non cine) for transmission to core laboratory
4. Scheduled for or undergone SPECT within 28 days prior to or following Study Day 1
Exclusion Criteria
2. Women who are pregnant or lactating
3. Known hypersensitivity or known contraindication to:
1. Dipyridamole
2. Ultrasound contrast agents (including PB127 and excipients)
3. Blood, blood products, albumin, egg whites, or protein
4. Use of caffeine or xanthine containing products within the 24 hours prior to PB127 administration on Study Day 1 (Stages 2 and 3)
5. Previous exposure to PB127
6. Inadequate echocardiographic windows
7. Heart transplant
8. Known right to left shunt, including atrial septal defect
9. History of CABG
10. Current uncontrolled ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter
11. Pacemaker or defibrillator
12. Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of IV nitroglycerin
13. Second degree or greater heart block
14. Hypertension (SPB \>200 and/or DBP \>110 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
15. Hypotension (SPB \<90 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
16. Severe aortic stenosis (\>100 mmHg peak transvalvar gradient or \<0.6 cm2 estimated valve area)
17. Pulmonary edema within the 7 days prior to Study Day 1
18. Resting oxygen saturation of less than 90%
19. Q wave MI or major surgery within the 7 days prior to Study Day 1
20. PTCA within the 28 days prior to Study Day 1
21. Chronic obstructive pulmonary disease or bronchospastic airway disease which, in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
22. Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of \>50 mmHg
23. Liver disease, characterized by or including one or more of the following
1. Elevated total bilirubin \> upper limit of normal
2. Currently elevated hepatic enzymes \>3X upper limit of normal
24. 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 or 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 clinical investigator's instructions
18 Years
ALL
Yes
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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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
Alfieri Cardiology
Newark, Delaware, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Midwest Cardiology Associates
Overland Park, Kansas, United States
The Center for Cardiovascular Studies Kramer and Crouse Cardiology
Shawnee Mission, Kansas, United States
Androscoggin Cardiovascular Associates
Auburn, Maine, United States
Cardiovascular Consultants
Kansas City, Missouri, United States
St. Louis University Medical Center
St Louis, Missouri, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
University of Pittsburgh Cardiovascular Institute
Pittsburgh, Pennsylvania, United States
Seton Healthcare Network Brackenridge Hospital
Austin, Texas, United States
Austin Heart
Austin, Texas, 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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127-013
Identifier Type: -
Identifier Source: org_study_id