Familiarization and Safety Study of PB127 Ultrasound Contrast Agent

Phase 2

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT00594698
• Lead Sponsor: Point Biomedical

Brief Summary

The purpose of this study is to evaluate preparation and administration of PB127, echocardiographic images obtained during PB127 administration, and evaluate the safety of PB127.

Detailed Description

The primary objectives of this clinical trial are:

1. To train potential Phase 3 investigational sites in the preparation and andministration of PB127

2. To train potential Phase 3 investigational sites in the acquisition of adequate images

3. To collect additional safety information regarding intravenous administration of PB127

4. To obtain a larger sample of images obtained with the Acuson Sequoia ultrasound system.

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Status Verified: 2008-01
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-04
• Study First Posted: 2008-01-16
• Last Update Submitted: 2008-07-01
• Last Update Posted: 2008-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Able to provide written informed consent
2. Scheduled for stress echocardiography, SPECT nuclear imaging and/or coronary angiography within the two weeks prior to or following Study Day 1
3. Adequate visualization of all myocardial segments in at least one imaging plane during screening non-contrast echocardiogram

Exclusion Criteria

1. Women who were pregnant or lactating

2. Known hypersensitivity or known contraindication to

   1. Dipyridamole
   2. Other ultrasound contrast agents
   3. Blood, blood products, albumin, egg, or protein

3. Use of caffeine or xanthine containing products within the 24 hours prior to PB127 MPE

4. Frequent (> 60/hour) or symptomatic ventricular ectopics at baseline

5. Atrial fibrillation

6. Permanent pacemaker or defibrillator

7. History of:

   1. Complex ventricular arrhythmia

   2. Chronic hepatitis

   3. Liver disease characterized by one or more of the following:

      • current jaundice
      • elevated bilirubin > upper limit of normal
      • currently elevated hepatic enzymes > 2X upper limit of normal
      • current or previous hepatic viral infection

   4. Chronic obstructive pulmonary disease (COPD) that, in the opinion of the Investigator, was significant enough to contraindicate dipyridamole

   5. Bronchospastic airway disease that, in the opinion of the Investigator, was significant enough to contraindicate dipyridamole

   6. Coronary artery bypass graft (CABG) within the 7 days prior to Study Day 1

   7. Heart transplant

   8. Q wave myocardial infarction within the 7 days prior to Study Day 1

   9. Cardiac intervention or surgery within the 7 days prior to Study Day 1

8. Hypertension (systolic blood pressure [SBP] >200 mmHg and diastolic blood pressure [DBP] >110 mmHg)

9. Hypotension (SBP <90 mmHg) documented within the 24 hours prior to Study Day 1

10. Significant valvular disease

    1. Severe aortic stenosis (>100 mmHg peak transvalvar gradient or <0.6 cm2 estimated valve area)
    2. Severe mitral regurgitation (usual clinical criteria plus or minus any of the following: proximal isovelocity surface area [PISA] >1 cm2, forward transmitral gradient of >2 m/sec, unexplained systolic flow reversal or blunting in the pulmonary veins)
    3. Severe mitral stenosis (<1.0 cm2 estimated valve area)

11. Congestive heart failure (New York Heart Association [NYHA] Class IV); NYHA classes are defined in Appendix D of the protocol (see Appendix 16.1.1)

12. Pulmonary edema within the 7 days prior to Study Day 1

13. Resting oxygen saturation of < 90%

14. Pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg by echo or catheter criteria on Study Day 1

15. Unstable angina, Canadian Cardiovascular Society (CCS) Class IV severity, with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin; CCS grading criteria are provided in Appendix E of the protocol (see Appendix 16.1.1)

16. Second degree heart block or greater

17. Use of intravenous or intracoronary contrast agent within the 24 hours prior to Study Day 1

18. Medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives, ie, drug dependence, psychiatric disorder, dementia, or other reasons for expected poor compliance with the Investigator's instructions; medical conditions, associated illness, or extenuating circumstances that made it unlikely that a patient can complete the clinical trial or follow-up evaluations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Technical adequacy and diagnostic quality of PB127 images	24 hours

Secondary Outcome Measures

Name	Time	Method
Compliance with image acquisition and Pb127 administration procedures	24 hours

Trial Locations

Locations (34)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

Washington Hospital Center Cardiovascular Research Institute; 🇺🇸 Washington, District of Columbia, United States

New England Medical Center; 🇺🇸 Boston, Massachusetts, United States

The Center for Cardiovascular Studies Kramer and Crouse Cardiology; 🇺🇸 Shawnee Mission, Kansas, United States

Long Beach VA Medical Center Cardiology Division; 🇺🇸 Long Beach, California, United States

San Francisco VA Medical Center NCIRE; 🇺🇸 San Francisco, California, United States

University of Pittsburgh Cardiovascular Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States

Northwest Cardiovascular Research Institute Spokane Cardiology; 🇺🇸 Spokane, Washington, United States

Oregon Health Sciences University; 🇺🇸 Portland, Oregon, United States

Endovascular Research, LLC; 🇺🇸 Eugene, Oregon, United States

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

MidWest Cardiologist Research; 🇺🇸 Columbus, Ohio, United States

University of Texas Health Sciences Center at San Antonio; 🇺🇸 San Antonio, Texas, United States

Austin Heart; 🇺🇸 Austin, Texas, United States

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States

Inland Cardiology; 🇺🇸 Spokane, Washington, United States

Michael Morgan, MD; 🇺🇸 Phoenix, Arizona, United States

Heartcare, P.C.; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

University of California San Diego Division of Cardiology; 🇺🇸 San Diego, California, United States

Krannert Institute of Cardiology; 🇺🇸 Indianapolis, Indiana, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

St. Louis University Medical Center; 🇺🇸 St. Louis, Missouri, United States

Androscoggin Cardiovascular Associates; 🇺🇸 Auburn, Maine, United States

Maine Cardiology Associates; 🇺🇸 South Portland, Maine, United States

Cardiovascular Consultants; 🇺🇸 Kansas City, Missouri, United States

The Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Presbyterian Hospital of Dallas; 🇺🇸 Dallas, Texas, United States

Methodist DeBakery Heart Center Cardiovascular Imaging Institute; 🇺🇸 Houston, Texas, United States

Harborview Medical Center Department of Cardiology; 🇺🇸 Seattle, Washington, United States

Dallas VA Medical Center; 🇺🇸 Dallas, Texas, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States