Safety and Efficacy Study of PB127 Ultrasound Contrast Agent in Patients With Suspected Coronary Artery Disease

Completed · Phase 3

Conditions studied: Coronary Artery Disease

In brief

This trial is to compare PB127 echocardiography to other heart imaging studies.

Key facts

Study ID

NCT00595244

Run by

Point Biomedical

People needed

456

Starts

2002-07-01

Expected to finish

2003-10-01

Last updated by the study team

2008-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• Able to provide written informed consent
• High (greater than 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

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
• Frequent (>60/hour) or symptomatic ventricular ectopics at baseline
• Hypertension (SPB >200 and/or DBP >110 mmHg on two consecutive readings within one hour of PB127 MCE)
• Hypotension (SPB <90 mmHg)
• 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 myocardial infarction within the 7 days prior to Study Day 1
• PTCA or CABG within the 7 days prior to Study Day 1
• Chronic Obstructive Pulmonary Disease (COPD) 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

• Michael Morgan, MD — Phoenix, Arizona, United States
• 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
• San Francisco VA Medical Center NCIRE — San Francisco, California, United States
• Washington Hospital Center Cardiovascular Research Institute — Washington D.C., District of Columbia, United States
• The Center for Cardiovascular Studies Kramer & Crouse Cardiology — Shawnee Mission, Kansas, United States
• New England Medical Center — Boston, Massachusetts, United States
• St. Louis University Medical Center — St Louis, Missouri, United States
• The Cleveland Clinic Foundation Department of Cardiology — Cleveland, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• University of Pittsburgh Cardiovascular Institute — Pittsburgh, Pennsylvania, United States
• University of Texas Health Sciences Center at San Antonio — San Antonio, Texas, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Harborview Medical Center Department of Cardiology — Seattle, Washington, United States
• Northwest Cardiovascular Research Institute Spokane Cardiology — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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