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Evaluation and Optimization of PB127 Myocardial Perfusion Echocardiography on Ultrasound Systems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00487903
Recruitment Status : Terminated (Discontinued PB127 development program for business reasons)
First Posted : June 19, 2007
Last Update Posted : July 3, 2008
Information provided by:
Point Biomedical

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Healthy Drug: PB127 for Injectable Suspension Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase 2 Trial of PB127 Myocardial Perfusion Echocardiography to Evaluate and Optimize Additional Ultrasound Imaging Systems
Study Start Date : September 2007
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Intervention Details:
    Drug: PB127 for Injectable Suspension
    0.062 mg/kg continuous IV (100-250 mL/hr) during echocardiogram, single dose, infusion not to exceed 60 minutes.
    Other Name: CARDIOsphere®

Primary Outcome Measures :
  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 [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

1. Men and women

  1. Normal volunteers (18 30 years old), with no history of CAD
  2. 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

Exclusion Criteria:

  1. Unable to provide written informed consent
  2. Women who are pregnant or lactating
  3. Known hypersensitivity or known contraindication to:

    1. Dipyridamole
    2. Ultrasound contrast agents (including PB127 and excipients)
    3. Blood, blood products, albumin, egg whites, or protein
  4. Use of caffeine or xanthine containing products within the 24 hours prior to PB127 administration on Study Day 1
  5. Previous exposure to PB127
  6. Inadequate echocardiographic windows
  7. Heart transplant
  8. Known right to left shunt, including atrial septal defect
  9. History of CABG
  10. Current uncontrolled ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter
  11. Pacemaker or defibrillator
  12. Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of IV nitroglycerin
  13. Second degree or greater heart block
  14. Hypertension (SPB >200 and/or DBP >110 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
  15. Hypotension (SPB <90 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
  16. Severe aortic stenosis (>100 mmHg peak transvalvar gradient or <0.6 cm2 estimated valve area)
  17. Pulmonary edema within the 7 days prior to Study Day 1
  18. Resting oxygen saturation of less than 90%
  19. Q wave MI within the 7 days prior to Study Day 1
  20. PTCA within the 28 days prior to Study Day 1
  21. Chronic obstructive pulmonary disease or bronchospastic airway disease which, in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
  22. Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg
  23. Liver disease, characterized by or including one or more of the following

    1. Elevated total bilirubin >upper limit of normal
    2. Currently elevated hepatic enzymes >3X upper limit of normal
  24. Medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives (i.e., drug dependence, psychiatric disorder, dementia, or associated illness); extenuating circumstances or medical conditions that make it unlikely that a patient can complete the clinical trial or follow up evaluations; or other reasons for expected poor compliance with the clinical investigator's instructions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487903

United States, Kansas
Midwest Cardiology Associates
Overland Park, Kansas, United States, 66209
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75226
Sponsors and Collaborators
Point Biomedical
Study Director: Alexander Ehlgen, MD, PhD POINT Biomedical Corp.

Responsible Party: Tom Ottoboni, PhD/Chief Operating Officer, Point Biomedical Corp.
ClinicalTrials.gov Identifier: NCT00487903     History of Changes
Other Study ID Numbers: 127-015
First Posted: June 19, 2007    Key Record Dates
Last Update Posted: July 3, 2008
Last Verified: July 2008

Keywords provided by Point Biomedical:
Coronary Artery Disease
Normal volunteers

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases