Dose Finding Study of PB127 Ultrasound Contrast Agent in Healthy Volunteers and Patients With Coronary Artery Disease
A Phase 2 Dose-Finding Clinical Trial of CARDIOsphere® (PB127) in Normal Volunteers and in Patients With Known or Suspected Coronary Artery Disease
1 other identifier
interventional
205
1 country
16
Brief Summary
The purpose of this study is to determine the dose of PB127 for detection and/or exclusion of coronary artery disease when used with cardiac ultrasound. This study also evaluates the safety of PB127.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 healthy
Started Nov 2006
16 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
November 1, 2006
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
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedApril 25, 2008
April 1, 2008
1.3 years
December 20, 2007
April 23, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To identify the minimum effective dose of PB127
24 hours
To identify the optimal stress infusion rate of PB127
24 hours
Secondary Outcomes (2)
To assess the efficacy of PB127 MPE using the dose and stress infusion rate identified in Stages 1 and 2
24 hours
To evaluate the safety of PB127
24 hours
Interventions
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.
Eligibility Criteria
You may qualify if:
- Stages 1 and 2
- Men and women
- Ages 18 30
- Normal volunteers
- No history (or suspicion) of CAD
- Stage 3
- Men and women with known or suspected CAD
- Ages 18 years and older
- Scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following Study Day 1
- Coronary angiography within 28 days prior to Study Day 1 and/or SPECT must have been non-interventional
- Coronary angiography images available in digital format (non cine) for transmission to core laboratory
- Scheduled for or undergone SPECT within 28 days prior to or following Study Day 1
You may not qualify if:
- Unable to provide written informed consent
- 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 whites, or protein
- Use of caffeine or xanthine containing products within the 24 hours prior to PB127 administration on Study Day 1 (Stages 2 and 3)
- Previous exposure to PB127
- Inadequate echocardiographic windows
- Heart transplant
- Known right to left shunt, including atrial septal defect
- History of CABG
- Current uncontrolled ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter
- Pacemaker or defibrillator
- Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of IV nitroglycerin
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Point Biomedicallead
Study Sites (16)
Long Beach VA Medical Center Cardiology Division
Long Beach, California, 90822, United States
University of California San Diego Division of Cardiology
San Diego, California, 92103, United States
Alfieri Cardiology
Newark, Delaware, 19713, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Midwest Cardiology Associates
Overland Park, Kansas, 66209, United States
The Center for Cardiovascular Studies Kramer and Crouse Cardiology
Shawnee Mission, Kansas, 66204, United States
Androscoggin Cardiovascular Associates
Auburn, Maine, 04210, United States
Cardiovascular Consultants
Kansas City, Missouri, 64111, United States
St. Louis University Medical Center
St Louis, Missouri, 63110, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oregon Health Sciences University
Portland, Oregon, 97239, 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
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 2
- 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
November 1, 2006
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
April 25, 2008
Record last verified: 2008-04