Safety and Efficacy Study of PB127 Ultrasound Contrast Agent in Patients With Suspected Coronary Artery Disease 007

This study has been completed.
Sponsor:
Information provided by:
Point Biomedical
ClinicalTrials.gov Identifier:
NCT00595673
First received: January 7, 2008
Last updated: July 1, 2008
Last verified: July 2008
  Purpose

This trial is to compare PB127 echocardiography to other heart imaging studies.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Point Biomedical:

Primary Outcome Measures:
  • To demonstrate the non-inferiority of the diagnostic performance of PB127 MCE versus stress SPECT in the detection and/or exclusion of significant obstructive CAD as defined by QCA or qualifying clinical outcome. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the concordance of PB127 MCE with stress SPECT in differentiating between reversible vs. fixed defects in patients with significant obstructive CAD [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • To compare the diagnostic performance of PB127 MCE with stress SPECT in identifying the location of stenosis as identified by coronary angiography. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 428
Study Start Date: July 2002
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: PB127 for injectable suspension
    0.175 mg/kg diluted in 150 mL Dextrose in Water 5% in glass bottles to be infused at 250 mL/hour until stead state achieve, 150 mL/hour during rest image acquisition, and 100-150 mL/hr during stress image acquistion. Single IV 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:   No
Criteria

Inclusion Criteria:

Stratum 1:

  1. Able to provide written informed consent
  2. Low (less than 10%) pre-test probability of CAD (Appendix D)
  3. Scheduled for clinically indicated stress echocardiography or stress SPECT within the 14 days prior to or following Study Day 1 (prior to coronary angiography) or coronary angiography within the 7 days following Study Day 1
  4. Technically adequate unreconstructed stress SPECT data or scheduled for clinically indicated stress SPECT within 14 days of Study Day 1 and prior to coronary angiography
  5. Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
  6. No evidence of a right-to-left shunt during non-contrast echocardiography

Stratum 2:

  1. Able to provide written informed consent
  2. Intermediate (10% to 90%) pre-test probability of CAD (Appendix D)
  3. Scheduled for clinically indicated coronary angiography within the 7 days following Study Day 1
  4. Technically adequate unreconstructed stress SPECT data or scheduled for stress SPECT within 14 days of Study Day 1 and prior to coronary angiography
  5. Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
  6. No evidence of a right-to-left shunt during non-contrast echocardiography

Stratum 3:

  1. Able to provide written informed consent
  2. High (greater than 90%) pre-test probability of CAD (Appendix D)
  3. Scheduled for clinically indicated coronary angiography within the 7 days following Study Day 1
  4. Technically adequate unreconstructed stress SPECT data or scheduled for stress SPECT within 14 days of Study Day 1 and prior to coronary angiography
  5. Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
  6. No evidence of a right-to-left shunt during non-contrast echocardiography

Exclusion Criteria:

  1. Women who are pregnant or lactating
  2. Known hypersensitivity or known contraindication to:

    1. Dipyridamole
    2. Ultrasound contrast agents (including PB127 and excipients)
    3. Blood, blood products, albumin, egg, or protein
  3. Use of caffeine or xanthine containing products within the 24 hours prior to PB127 MCE
  4. Previous exposure to PB127 Ultrasound Contrast Agent
  5. Heart transplant
  6. Known right-to-left shunt including atrial septal defect
  7. Current or history of uncontrolled ventricular tachycardia
  8. Current atrial fibrillation, atrial tachycardia, or atrial flutter
  9. Pacemaker or defibrillator
  10. Unstable cardiac status

    1. Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin (See Appendix F)
    2. Second-degree or greater heart block
    3. Frequent (>60/hour) or symptomatic ventricular ectopics at baseline
    4. Hypertension (SPB >200 and/or DBP >110 mmHg on two consecutive readings within one hour of PB127 MCE)
    5. Hypotension (SPB <90 mmHg)
    6. Severe aortic stenosis (>100 mmHg peak transvalvar gradient or <0.6 cm2 estimated valve area)
    7. Pulmonary edema within the 7 days prior to Study Day 1
    8. Resting oxygen saturation of less than 90%
    9. Q-wave myocardial infarction within the 7 days prior to Study Day 1
    10. PTCA or CABG within the 7 days prior to Study Day 1
  11. Chronic Obstructive Pulmonary Disease (COPD) or bronchospastic airway disease which, in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
  12. Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg
  13. Use of intravenous or intracoronary contrast agent other than thallium or technetium within the 24 hours prior to Study Day 1
  14. Liver disease (i.e., current or previous hepatic viral infection, chronic hepatitis) characterized by one or more of the following

    1. Current jaundice
    2. Elevated bilirubin > upper limit of normal
    3. Currently elevated hepatic enzymes > 2X upper limit of normal
  15. 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, 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 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: NCT00595673

Locations
United States, Arizona
Heartcare, P.C.
Scottsdale, Arizona, United States, 85258
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Indiana
Krannert Institute of Cardiology
Indianapolis, Indiana, United States, 46202
United States, Kansas
The Center for Cardiovascular Studies Kramer & Crouse Cardiology
Shawnee Mission, Kansas, United States, 66204
United States, Maine
Androscoggin Cardiovascular Associates
Auburn, Maine, United States, 04210
Maine Cardiology Associates
South Portland, Maine, United States, 04106
United States, Missouri
Cardiovascular Consultants
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
St. Luke's Roosevelt Hospital Echocardiography Lab
New York, New York, United States, 10025
United States, Ohio
MidWest Cardiologist Research
Columbus, Ohio, United States, 43214
United States, Oregon
Endovascular Research, LLC
Eugene, Oregon, United States, 97401
United States, Texas
Austin Heart
Austin, Texas, United States, 78705
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75231
Methodist DeBakery Heart Center Cardiovascular Imaging Institute
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Washington
Inland 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/Chief Operating Officer, POINT Biomedical Corp
ClinicalTrials.gov Identifier: NCT00595673     History of Changes
Other Study ID Numbers: 127-007
Study First Received: January 7, 2008
Last Updated: July 1, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Point Biomedical:
Perfusion
Echocardiograpy
SPECT
angiography
Chest pain

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 August 28, 2014