Safety and Efficacy Study of PB127 Ultrasound Contrast Agent for Diagnosis of Coronary Artery Disease
NCT ID: NCT00584896
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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TERMINATED
PHASE3
1000 participants
INTERVENTIONAL
2007-10-31
2008-07-31
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
0.062 mg/kg continuous IV infusion (100-250 mL/hr) during echocardiography, not to exceed 60 minutes infusion, single dose.
Other Intervention Names
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Eligibility Criteria
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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 Study Day 1
4. Previous exposure to PB127 Ultrasound Contrast Agent
5. Major surgery within 7 days prior to Study Day 1 (requiring general anesthesia and/or overnight stay)
6. Heart transplant or history of CABG
7. Known hemodynamically significant or symptomatic right-to-left shunt (including shunts that are associated with prior TIAs or strokes)
8. Recent history of sustained ventricular tachycardia
9. Pacemaker or defibrillator
10. Unstable cardiac status
1. Unstable angina grade CCS Class IV severity (any physical activity causes limiting symptoms; symptoms may be present at rest in a patient with prior exertional angina) with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin
2. Decompensated heart failure
3. Second-degree or greater heart block, sick sinus syndrome
4. Frequent (\>60/hour) or symptomatic ventricular ectopics at baseline
5. Hypertension (SBP \>200 and/or DBP \>110 mmHg on two consecutive readings within one hour of PB127 MPE)
6. Hypotension (SBP \<90 mmHg)
7. Severe aortic stenosis (\>40 mmHg mean gradient or \<0.6 cm2/m2 valve area index)
8. Pulmonary edema within the 7 days prior to Study Day 1
9. Resting oxygen saturation of less than 90% on room air
11. Myocardial infarction or cerebral vascular accident / transient ischemic attack within the 28 days prior to Study Day 1
12. Chronic Obstructive Pulmonary Disease (COPD) or bronchospastic airway disease, which in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
13. Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of \>50 mmHg
14. Liver disease 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
4. Current or previous hepatic viral infection (not including hepatitis A)
5. Chronic hepatitis
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 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
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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University of Arizona Saver Heart Clinic
Tucson, Arizona, United States
Cardiovascular Associates of the Peninsula
Burlingame, California, United States
Long Beach VA Medical Center Cardiology Division
Long Beach, California, United States
Cedars Sinai Medical Center Division of Cardiology
Los Angeles, California, United States
Sutter Roseville Medical Center
Roseville, 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
Connecticut Clinical Research
Bridgeport, Connecticut, United States
Alfieri Cardiology
Newark, Delaware, United States
Washington Hospital Center Cardiovascular Research Institute
Washington D.C., District of Columbia, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Midwest Cardiology Associates
Overland Park, Kansas, United States
The Center for Cardiovascular Studies Kramer & Crouse Cardiology
Shawnee Mission, Kansas, United States
Western Baptist Hospital The Heart Group
Paducah, Kentucky, United States
Androscoggin Cardiovascular Associates
Auburn, Maine, United States
Maine Cardiology Associates
South Portland, Maine, United States
Brigham & Women's Hosptial
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic Department of Cardiology
Rochester, Minnesota, United States
Cardiovascular Consultants
Kansas City, Missouri, United States
St. Louis University Medical Center
St Louis, Missouri, United States
North Shore University Hospital
Manhasset, New York, United States
St. Luke's Roosevelt Hospital Echocardiography Lab
New York, New York, United States
Stonybrook University Medical Center
Stony Brook, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Carolina Cardiology Associates
High Point, North Carolina, United States
The Cleveland Clinic Foundation Department of Cardiology
Cleveland, Ohio, United States
Ohio State University College of Medicine and Public Health
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center VA Medical Center
Oklahoma City, Oklahoma, 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
Consultants in Cardiology
Fort Worth, Texas, United States
University of Texas Division of Cardiology
Galveston, Texas, United States
Methodist DeBakery Heart Center Cardiovascular Imaging Institute
Houston, Texas, United States
University of Texas Health Science Center Memorial Hermann Heart & Vascular Institute
Houston, Texas, United States
Harborview Medical Center Department of Cardiology
Seattle, Washington, United States
Heart Clinics Northwest
Spokane, 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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127-014
Identifier Type: -
Identifier Source: org_study_id