Safety and Efficacy Study of PB127 Ultrasound Contrast Agent in Patients With Suspected Coronary Artery Disease 007
1 other identifier
interventional
428
1 country
19
Brief Summary
This trial is to compare PB127 echocardiography to other heart imaging studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 coronary-artery-disease
Started Jul 2002
Shorter than P25 for phase_3 coronary-artery-disease
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 7, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedJuly 3, 2008
July 1, 2008
1.3 years
January 7, 2008
July 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To demonstrate the non-inferiority of the diagnostic performance of PB127 MCE versus stress SPECT in the detection and/or exclusion of significant obstructive CAD as defined by QCA or qualifying clinical outcome.
90 days
Secondary Outcomes (2)
To assess the concordance of PB127 MCE with stress SPECT in differentiating between reversible vs. fixed defects in patients with significant obstructive CAD
28 days
To compare the diagnostic performance of PB127 MCE with stress SPECT in identifying the location of stenosis as identified by coronary angiography.
28 days
Interventions
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.
Eligibility Criteria
You may qualify if:
- Stratum 1:
- Able to provide written informed consent
- Low (less than 10%) pre-test probability of CAD (Appendix D)
- 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
- 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
- Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
- No evidence of a right-to-left shunt during non-contrast echocardiography
- Stratum 2:
- Able to provide written informed consent
- Intermediate (10% to 90%) pre-test probability of CAD (Appendix D)
- Scheduled for clinically indicated coronary angiography within the 7 days following Study Day 1
- Technically adequate unreconstructed stress SPECT data or scheduled for stress SPECT within 14 days of Study Day 1 and prior to coronary angiography
- Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
- No evidence of a right-to-left shunt during non-contrast echocardiography
- Stratum 3:
- +6 more 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 PB127 MCE
- Previous exposure to PB127 Ultrasound Contrast Agent
- Heart transplant
- Known right-to-left shunt including atrial septal defect
- Current or history of uncontrolled ventricular tachycardia
- Current atrial fibrillation, atrial tachycardia, or atrial flutter
- Pacemaker or defibrillator
- Unstable cardiac status
- Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin (See Appendix F)
- Second-degree or greater heart block
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Point Biomedicallead
Study Sites (19)
Heartcare, P.C.
Scottsdale, Arizona, 85258, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259, United States
University of California San Francisco
San Francisco, California, 94143, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Krannert Institute of Cardiology
Indianapolis, Indiana, 46202, United States
The Center for Cardiovascular Studies Kramer & Crouse Cardiology
Shawnee Mission, Kansas, 66204, United States
Androscoggin Cardiovascular Associates
Auburn, Maine, 04210, United States
Maine Cardiology Associates
South Portland, Maine, 04106, United States
Cardiovascular Consultants
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
St. Luke's Roosevelt Hospital Echocardiography Lab
New York, New York, 10025, United States
Mount Sinai Hospital
New York, New York, 10029, United States
MidWest Cardiologist Research
Columbus, Ohio, 43214, United States
Endovascular Research, LLC
Eugene, Oregon, 97401, United States
Austin Heart
Austin, Texas, 78705, United States
Presbyterian Hospital of Dallas
Dallas, Texas, 75231, United States
Methodist DeBakery Heart Center Cardiovascular Imaging Institute
Houston, Texas, 77030, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Inland 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
January 7, 2008
First Posted
January 16, 2008
Study Start
July 1, 2002
Primary Completion
October 1, 2003
Study Completion
October 1, 2003
Last Updated
July 3, 2008
Record last verified: 2008-07