Familiarization and Safety Study of PB127 Ultrasound Contrast Agent

This study has been completed.
Sponsor:
Information provided by:
Point Biomedical
ClinicalTrials.gov Identifier:
NCT00594698
First received: January 4, 2008
Last updated: July 1, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: PB127 for injectable suspension
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Familiarization and Safety Study of Myocardial Perfusion Contrast Echocardiography With PB127 Ultrasound Contrast Agent in Patients With Suspected Obstructive Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Point Biomedical:

Primary Outcome Measures:
  • Technical adequacy and diagnostic quality of PB127 images [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compliance with image acquisition and Pb127 administration procedures [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: February 2002
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: PB127 for injectable suspension
    0.175 mg/kg diluted in 150 mL 5% Dextrose for Injection in glass bottles, to be administered as a single continuous infusion during image acquisition. Infusion time not to exceed 60 minutes
    Other Name: CARDIOsphere®
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594698

  Show 34 Study Locations
Sponsors and Collaborators
Point Biomedical
Investigators
Study Director: Alexander Ehlgen, MD, PhD POINT Biomedical Corp.
  More Information

No publications provided

Responsible Party: Tom Ottobonie, PhD/Chief Operating Officer, POINT Biomedical Corp.
ClinicalTrials.gov Identifier: NCT00594698     History of Changes
Other Study ID Numbers: 127-005
Study First Received: January 4, 2008
Last Updated: July 1, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Point Biomedical:
Perfusion
Echocardiography
Cardiac angiography
SPECT

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 April 23, 2014