Study Stopped
Discontinued PB127 development program for business reasons
Evaluation and Optimization of PB127 Myocardial Perfusion Echocardiography on Ultrasound Systems
A Phase 2 Trial of PB127 Myocardial Perfusion Echocardiography to Evaluate and Optimize Additional Ultrasound Imaging Systems
1 other identifier
interventional
40
1 country
3
Brief Summary
The purpose of this clinical trial is to evaluate various commercially available ultrasound systems and to identify imaging parameters to be used with these systems (along with the contrast agent PB127) as well as to further evaluate the safety of PB127.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 coronary-artery-disease
Started Sep 2007
Shorter than P25 for phase_2 coronary-artery-disease
3 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
First Submitted
Initial submission to the registry
June 15, 2007
CompletedFirst Posted
Study publicly available on registry
June 19, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
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
CompletedJuly 3, 2008
July 1, 2008
6 months
June 15, 2007
July 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determination of optimal machine settings and imaging parameters for myocardial perfusion for a variety of ultrasound imaging systems to be used in upcoming clinical trials
24 hours
Interventions
0.062 mg/kg continuous IV (100-250 mL/hr) during echocardiogram, single dose, infusion not to exceed 60 minutes.
Eligibility Criteria
You may qualify if:
- \. Men and women
- Normal volunteers (18 30 years old), with no history of CAD
- Patients (≥ 18 years old) with known or suspected CAD, scheduled for or undergone clinically indicated coronary angiography 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
- 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 (3)
Midwest Cardiology Associates
Overland Park, Kansas, 66209, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Baylor Research Institute
Dallas, Texas, 75226, 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
June 15, 2007
First Posted
June 19, 2007
Study Start
September 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
July 3, 2008
Record last verified: 2008-07