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

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. Identifier: NCT00584818
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : April 25, 2008
Information provided by:
Point Biomedical

Brief Summary:
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase 2 Dose-Finding Clinical Trial of CARDIOsphere® (PB127) in Normal Volunteers and in Patients With Known or Suspected Coronary Artery Disease
Study Start Date : November 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: PB127 for Injectable Suspension

    Stages 1 & 2 0.009 - 0.204 mg/kg continuous IV during rest and stress conditions. Infusion rate of 50 - 125 mL/hr will be adjusted for image quality and diagnostic quality. Infusion limited to 60 minutes or less.

    Stage 3 - will utilize infusion rate and dose established in Stages 1 & 2. 0.062 mg/kg continuous IV infusion at 150 mL/hr during rest and 100 mL/hr during stress conditions.

    Other Name: CARDIOsphere®

Primary Outcome Measures :
  1. To identify the minimum effective dose of PB127 [ Time Frame: 24 hours ]
  2. To identify the optimal stress infusion rate of PB127 [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. To assess the efficacy of PB127 MPE using the dose and stress infusion rate identified in Stages 1 and 2 [ Time Frame: 24 hours ]
  2. To evaluate the safety of PB127 [ 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:

Stages 1 and 2

  1. Men and women
  2. Ages 18 30
  3. Normal volunteers
  4. No history (or suspicion) of CAD

Stage 3

  1. Men and women with known or suspected CAD
  2. Ages 18 years and older
  3. Scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following Study Day 1

    1. Coronary angiography within 28 days prior to Study Day 1 and/or SPECT must have been non-interventional
    2. Coronary angiography images available in digital format (non cine) for transmission to core laboratory
  4. Scheduled for or undergone SPECT 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 (Stages 2 and 3)
  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 or major surgery 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 identifier (NCT number): NCT00584818

United States, California
Long Beach VA Medical Center Cardiology Division
Long Beach, California, United States, 90822
University of California San Diego Division of Cardiology
San Diego, California, United States, 92103
United States, Delaware
Alfieri Cardiology
Newark, Delaware, United States, 19713
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Kansas
Midwest Cardiology Associates
Overland Park, Kansas, United States, 66209
The Center for Cardiovascular Studies Kramer and Crouse Cardiology
Shawnee Mission, Kansas, United States, 66204
United States, Maine
Androscoggin Cardiovascular Associates
Auburn, Maine, United States, 04210
United States, Missouri
Cardiovascular Consultants
Kansas City, Missouri, United States, 64111
St. Louis University Medical Center
St. Louis, Missouri, United States, 63110
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburgh Cardiovascular Institute
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Seton Healthcare Network Brackenridge Hospital
Austin, Texas, United States, 78701
Austin Heart
Austin, Texas, United States, 78705
United States, Washington
Inland Cardiology
Spokane, Washington, United States, 99204
Northwest Cardiovascular Research Institute Spokane Cardiology
Spokane, Washington, United States, 99204
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. Identifier: NCT00584818     History of Changes
Other Study ID Numbers: 127-013
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: April 25, 2008
Last Verified: April 2008

Keywords provided by Point Biomedical:
coronary artery disease
chest pain
healthy volunteers

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