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

This study has been completed.
Sponsor:
Information provided by:
Point Biomedical
ClinicalTrials.gov Identifier:
NCT00584818
First received: December 20, 2007
Last updated: April 23, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Healthy
Coronary Artery Disease
Drug: PB127 for Injectable Suspension
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Point Biomedical:

Primary Outcome Measures:
  • To identify the minimum effective dose of PB127 [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • To identify the optimal stress infusion rate of PB127 [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the efficacy of PB127 MPE using the dose and stress infusion rate identified in Stages 1 and 2 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • To evaluate the safety of PB127 [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 205
Study Start Date: November 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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®
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584818

Locations
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
Austin Heart
Austin, Texas, United States, 78705
Seton Healthcare Network Brackenridge Hospital
Austin, Texas, United States, 78701
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
Investigators
Study Director: Alexander Ehlgen, MD, PhD POINT Biomedical Corp.
  More Information

No publications provided

Responsible Party: Tom Ottoboni PhD/Chief Operating Officer, POINT Biomedical Corp.
ClinicalTrials.gov Identifier: NCT00584818     History of Changes
Other Study ID Numbers: 127-013
Study First Received: December 20, 2007
Last Updated: April 23, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Point Biomedical:
coronary artery disease
chest pain
healthy volunteers
SPECT
angiogram
ultrasound
echocardiogram
perfusion

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

ClinicalTrials.gov processed this record on October 21, 2014