Evaluation and Optimization of PB127 Myocardial Perfusion Echocardiography on Ultrasound Systems

Stopped early · Phase 2

Conditions studied: Coronary Artery Disease, Healthy

In brief

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.

Key facts

Study ID

NCT00487903

Run by

Point Biomedical

People needed

40

Starts

2007-09-01

Expected to finish

2008-03-01

Last updated by the study team

2008-07-03

Who can join

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

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
• 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 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

• Midwest Cardiology Associates — Overland Park, Kansas, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Baylor Research Institute — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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