Familiarization and Safety Study of PB127 Ultrasound Contrast Agent

July 1, 2008 updated by: Point Biomedical

A Familiarization and Safety Study of Myocardial Perfusion Contrast Echocardiography With PB127 Ultrasound Contrast Agent in Patients With Suspected Obstructive Coronary Artery Disease

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.

Study Overview

Status

Completed

Conditions

Coronary Artery Disease

Intervention / Treatment

Drug: PB127 for injectable suspension

Detailed Description

The primary objectives of this clinical trial are:

To train potential Phase 3 investigational sites in the preparation and andministration of PB127
To train potential Phase 3 investigational sites in the acquisition of adequate images
To collect additional safety information regarding intravenous administration of PB127
To obtain a larger sample of images obtained with the Acuson Sequoia ultrasound system.

Study Type

Interventional

Enrollment (Actual)

150

Phase

Phase 2
Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arizona
  - Phoenix, Arizona, United States, 85018
    - Michael Morgan, MD
  - Scottsdale, Arizona, United States, 85259
    - Mayo Clinic Scottsdale
  - Scottsdale, Arizona, United States, 85258
    - Heartcare, P.C.
- California
  - Long Beach, California, United States, 90822
    - Long Beach VA Medical Center Cardiology Division
  - San Diego, California, United States, 92103
    - University of California San Diego Division of Cardiology
  - San Francisco, California, United States, 94143
    - University of California San Francisco
  - San Francisco, California, United States, 94121
    - San Francisco VA Medical Center NCIRE
  - Stanford, California, United States, 94305
    - Stanford University Medical Center
- District of Columbia
  - Washington, District of Columbia, United States, 20010
    - Washington Hospital Center Cardiovascular Research Institute
- Illinois
  - Chicago, Illinois, United States, 60637
    - University of Chicago Medical Center
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Krannert Institute of Cardiology
- Kansas
  - Shawnee Mission, Kansas, United States, 66204
    - The Center for Cardiovascular Studies Kramer and Crouse Cardiology
- Maine
  - Auburn, Maine, United States, 04210
    - Androscoggin Cardiovascular Associates
  - South Portland, Maine, United States, 04106
    - Maine Cardiology Associates
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - New England Medical Center
- Missouri
  - Kansas City, Missouri, United States, 64111
    - Cardiovascular Consultants
  - St. Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - St. Louis, Missouri, United States, 63110
    - St. Louis University Medical Center
- New York
  - New York, New York, United States, 10029
    - Mount Sinai Hospital
- Ohio
  - Cleveland, Ohio, United States, 44195
    - The Cleveland Clinic Foundation
  - Columbus, Ohio, United States, 43214
    - MidWest Cardiologist Research
- Oregon
  - Eugene, Oregon, United States, 97401
    - Endovascular Research, LLC
  - Portland, Oregon, United States, 97239
    - Oregon Health Sciences University
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15213
    - University of Pittsburgh Cardiovascular Institute
- Texas
  - Austin, Texas, United States, 78705
    - Austin Heart
  - Dallas, Texas, United States, 75216
    - Dallas VA Medical Center
  - Dallas, Texas, United States, 75231
    - Presbyterian Hospital of Dallas
  - Houston, Texas, United States, 77030
    - Methodist DeBakery Heart Center Cardiovascular Imaging Institute
  - San Antonio, Texas, United States, 78229
    - University of Texas Health Sciences Center at San Antonio
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia Health System
- Washington
  - Seattle, Washington, United States, 98101
    - Virginia Mason Medical Center
  - Seattle, Washington, United States, 98104
    - Harborview Medical Center Department of Cardiology
  - Spokane, Washington, United States, 99204
    - Northwest Cardiovascular Research Institute Spokane Cardiology
  - Spokane, Washington, United States, 99204
    - Inland Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Able to provide written informed consent
Scheduled for stress echocardiography, SPECT nuclear imaging and/or coronary angiography within the two weeks prior to or following Study Day 1
Adequate visualization of all myocardial segments in at least one imaging plane during screening non-contrast echocardiogram

Exclusion Criteria:

Women who were pregnant or lactating
Known hypersensitivity or known contraindication to
1. Dipyridamole
2. Other ultrasound contrast agents
3. Blood, blood products, albumin, egg, or protein
Use of caffeine or xanthine containing products within the 24 hours prior to PB127 MPE
Frequent (> 60/hour) or symptomatic ventricular ectopics at baseline
Atrial fibrillation
Permanent pacemaker or defibrillator
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
Hypertension (systolic blood pressure [SBP] >200 mmHg and diastolic blood pressure [DBP] >110 mmHg)
Hypotension (SBP <90 mmHg) documented within the 24 hours prior to Study Day 1
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)
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)
Pulmonary edema within the 7 days prior to Study Day 1
Resting oxygen saturation of < 90%
Pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg by echo or catheter criteria on Study Day 1
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)
Second degree heart block or greater
Use of intravenous or intracoronary contrast agent within the 24 hours prior to Study Day 1
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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Technical adequacy and diagnostic quality of PB127 images Time Frame: 24 hours	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Compliance with image acquisition and Pb127 administration procedures Time Frame: 24 hours	24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Point Biomedical

Investigators

Study Director: Alexander Ehlgen, MD, PhD, POINT Biomedical Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

September 1, 2003

Study Completion (Actual)