Study Stopped
Discontinued PB127 development program for business reasons
Safety and Efficacy Study of PB127 Ultrasound Contrast Agent for Diagnosis of Coronary Artery Disease
POINT II
A Phase 3 Clinical Trial to Assess Perfusion and Obstruction Identified by Non-Invasive Technology Using PB127 Ultrasound Contrast Agent in Patients With Suspected Obstructive Coronary Artery Disease II
1 other identifier
interventional
1,000
1 country
40
Brief Summary
The purpose of this study is to determine if the use of PB127 with cardiac ultrasound assists in the diagnosis or exclusion of coronary artery disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 coronary-artery-disease
Started Oct 2007
Shorter than P25 for phase_3 coronary-artery-disease
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
January 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedJuly 3, 2008
July 1, 2008
9 months
December 20, 2007
July 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the diagnostic performance of PB127 MPE for the detection and/or exclusion of significant obstructive coronary artery disease as defined by qualitative coronary angiography or qualifying clinical outcome
72 hours, 6 months
Secondary Outcomes (4)
To compare the diagnostic performance of PB127 MPE to SPECT for the detection and/or exclusion of significant obstructive coronary artery disease.
72 hours, 6 months
To assess the concordance of PB127 MPE with SPECT in the differentiation of defect type (fixed versus reversible) in patients with significant obstructive CAD.
72 hours, 6 months
To evaluate the diagnostic performance characteristics of PB127 MPE for identifying the location of significant obstructive CAD as defined by quantitative coronary angiography
72 hours
To assess the change in diagnostic certainty when PB127 MPE and relevant clinical information are combined over relevant clinical information alone.
72 hours, 6 months
Interventions
0.062 mg/kg continuous IV infusion (100-250 mL/hr) during echocardiography, not to exceed 60 minutes infusion, single dose.
Eligibility Criteria
You may not qualify if:
- Women who are pregnant or lactating
- Known hypersensitivity or known contraindication to:
- Dipyridamole
- Ultrasound contrast agents (including PB127 and excipients)
- Blood, blood products, albumin, egg, or protein
- Use of caffeine or xanthine containing products within the 24 hours prior to Study Day 1
- Previous exposure to PB127 Ultrasound Contrast Agent
- Major surgery within 7 days prior to Study Day 1 (requiring general anesthesia and/or overnight stay)
- Heart transplant or history of CABG
- Known hemodynamically significant or symptomatic right-to-left shunt (including shunts that are associated with prior TIAs or strokes)
- Recent history of sustained ventricular tachycardia
- Pacemaker or defibrillator
- Unstable cardiac status
- 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
- Decompensated heart failure
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Point Biomedicallead
Study Sites (40)
University of Arizona Saver Heart Clinic
Tucson, Arizona, 85724, United States
Cardiovascular Associates of the Peninsula
Burlingame, California, 94010, United States
Long Beach VA Medical Center Cardiology Division
Long Beach, California, 90822, United States
Cedars Sinai Medical Center Division of Cardiology
Los Angeles, California, 90048, United States
Sutter Roseville Medical Center
Roseville, California, 95661, United States
University of California San Diego Division of Cardiology
San Diego, California, 92103, United States
San Francisco VA Medical Center NCIRE
San Francisco, California, 94121, United States
Connecticut Clinical Research
Bridgeport, Connecticut, 06606, United States
Alfieri Cardiology
Newark, Delaware, 19713, United States
Washington Hospital Center Cardiovascular Research Institute
Washington D.C., District of Columbia, 20010, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Midwest Cardiology Associates
Overland Park, Kansas, 66209, United States
The Center for Cardiovascular Studies Kramer & Crouse Cardiology
Shawnee Mission, Kansas, 66204, United States
Western Baptist Hospital The Heart Group
Paducah, Kentucky, 42001, United States
Androscoggin Cardiovascular Associates
Auburn, Maine, 04210, United States
Maine Cardiology Associates
South Portland, Maine, 04106, United States
Brigham & Women's Hosptial
Boston, Massachusetts, 02115, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic Department of Cardiology
Rochester, Minnesota, 55905, United States
Cardiovascular Consultants
Kansas City, Missouri, 64111, United States
St. Louis University Medical Center
St Louis, Missouri, 63110, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
St. Luke's Roosevelt Hospital Echocardiography Lab
New York, New York, 10025, United States
Stonybrook University Medical Center
Stony Brook, New York, 11794, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Carolina Cardiology Associates
High Point, North Carolina, 27262, United States
The Cleveland Clinic Foundation Department of Cardiology
Cleveland, Ohio, 44195, United States
Ohio State University College of Medicine and Public Health
Columbus, Ohio, 43210, United States
University of Oklahoma Health Sciences Center VA Medical Center
Oklahoma City, Oklahoma, United States
University of Pittsburgh Cardiovascular Institute
Pittsburgh, Pennsylvania, 15213, United States
Seton Healthcare Network Brackenridge Hospital
Austin, Texas, 78701, United States
Austin Heart
Austin, Texas, 78705, United States
Consultants in Cardiology
Fort Worth, Texas, 76104, United States
University of Texas Division of Cardiology
Galveston, Texas, 77555, United States
Methodist DeBakery Heart Center Cardiovascular Imaging Institute
Houston, Texas, 77030, United States
University of Texas Health Science Center Memorial Hermann Heart & Vascular Institute
Houston, Texas, 77030, United States
Harborview Medical Center Department of Cardiology
Seattle, Washington, 98104, United States
Heart Clinics Northwest
Spokane, Washington, 99204, United States
Inland Cardiology
Spokane, Washington, 99204, United States
Northwest Cardiovascular Research Institute Spokane Cardiology
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alexander Ehlgen, MD, PhD
POINT Biomedical Corp
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 20, 2007
First Posted
January 2, 2008
Study Start
October 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
July 3, 2008
Record last verified: 2008-07