Dose Finding Study of PB127 Ultrasound Contrast Agent in Healthy Volunteers and Patients With Coronary Artery Disease

Completed · Phase 2

Conditions studied: Healthy, Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00584818

Run by

Point Biomedical

People needed

205

Starts

2006-11-01

Expected to finish

2008-03-01

Last updated by the study team

2008-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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
• Second degree or greater heart block
• Hypertension (SPB >200 and/or DBP >110 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
• Hypotension (SPB <90 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
• Severe aortic stenosis (>100 mmHg peak transvalvar gradient or <0.6 cm2 estimated valve area)
• Pulmonary edema within the 7 days prior to Study Day 1
• Resting oxygen saturation of less than 90%
• Q wave MI or major surgery within the 7 days prior to Study Day 1
• PTCA within the 28 days prior to Study Day 1
• Chronic obstructive pulmonary disease or bronchospastic airway disease which, in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
• Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg

Where it is running

• Long Beach VA Medical Center Cardiology Division — Long Beach, California, United States
• University of California San Diego Division of Cardiology — San Diego, California, United States
• Alfieri Cardiology — Newark, Delaware, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Midwest Cardiology Associates — Overland Park, Kansas, United States
• The Center for Cardiovascular Studies Kramer and Crouse Cardiology — Shawnee Mission, Kansas, United States
• Androscoggin Cardiovascular Associates — Auburn, Maine, United States
• Cardiovascular Consultants — Kansas City, Missouri, United States
• St. Louis University Medical Center — St Louis, Missouri, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, 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
• Inland Cardiology — Spokane, Washington, United States
• Northwest Cardiovascular Research Institute Spokane Cardiology — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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