Evaluation and Optimization of PB127 Myocardial Perfusion Echocardiography on Ultrasound Systems

This study has been terminated.
(Discontinued PB127 development program for business reasons)
Sponsor:
Information provided by:
Point Biomedical
ClinicalTrials.gov Identifier:
NCT00487903
First received: June 15, 2007
Last updated: July 1, 2008
Last verified: July 2008
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase 2 Trial of PB127 Myocardial Perfusion Echocardiography to Evaluate and Optimize Additional Ultrasound Imaging Systems

Resource links provided by NLM:


Further study details as provided by Point Biomedical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2007
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
    0.062 mg/kg continuous IV (100-250 mL/hr) during echocardiogram, single dose, infusion not to exceed 60 minutes.
    Other Name: CARDIOsphere®
  Eligibility

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

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
  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: NCT00487903

Locations
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
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: NCT00487903     History of Changes
Other Study ID Numbers: 127-015
Study First Received: June 15, 2007
Last Updated: July 1, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Point Biomedical:
Coronary Artery Disease
Echocardiogram
Contrast
Perfusion
Ultrasound
Normal volunteers

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

ClinicalTrials.gov processed this record on September 18, 2014