Long-Term Follow-up Study of Patients Who Received PB127 Ultrasound Imaging Agent

July 1, 2008 updated by: Point Biomedical

Long-Term Follow-Up of Selected Patients Enrolled in Phase 3 Clinical Trial 127-014 Using PB127 Ultrasound Imaging Agent

The purpose of this study is to collect longer term follow-up information concerning health and survival on selected patients who received PB127 for injectable suspension in the pivotal trial (127-014).

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

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
      • Tucson, Arizona, United States, 85724
        • University of Arizona Saver Heart Clinic
    • California
      • Burlingame, California, United States, 94010
        • Cardiovascular Associates of the Peninsula
      • Long Beach, California, United States, 90822
        • Long Beach VA Medical Center Cardiology Division
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center Division of Cardiology
      • Roseville, California, United States, 95661
        • Sutter Roseville Medical Center
      • San Diego, California, United States, 92103
        • University of California San Diego Division of Cardiology
      • San Francisco, California, United States, 94121
        • San Francisco VA Medical Center NCIRE
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Connecticut Clinical Research
    • Delaware
      • Newark, Delaware, United States, 19713
        • Alfieri Cardiology
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center Cardiovascular Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Midwest Cardiology Associates
      • Shawnee Mission, Kansas, United States, 66204
        • The Center for Cardiovascular Studies Kramer & Crouse Cardiology
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Western Baptist Hospital The Heart Group
    • Maine
      • Auburn, Maine, United States, 04210
        • Androscoggin Cardiovascular Associates
      • South Portland, Maine, United States, 04106
        • Maine Cardiology Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hosptial
    • Michigan
      • Detroit, Michigan, United States
        • Henry Ford Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Department of Cardiology
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Cardiovascular Consultants
      • St. Louis, Missouri, United States, 63110
        • St. Louis University Medical Center
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10025
        • St. Luke's Roosevelt Hospital Echocardiography Lab
      • Stonybrook, New York, United States, 11794
        • Stonybrook University Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • High Point, North Carolina, United States, 27262
        • Carolina Cardiology Associates
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation Department of Cardiology
      • Columbus, Ohio, United States, 43210
        • Ohio State University College of Medicine and Public Health
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Cardiovascular Institute
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Heart
      • Austin, Texas, United States, 78701
        • Seton Healthcare Network Brackenridge Hospital
      • Fort Worth, Texas, United States, 76104
        • Consultants in Cardiology
      • Galveston, Texas, United States, 77555
        • University of Texas Division of Cardiology
      • Houston, Texas, United States, 77030
        • Methodist DeBakery Heart Center Cardiovascular Imaging Institute
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center Memorial Hermann Heart & Vascular Institute
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center Department of Cardiology
      • Spokane, Washington, United States, 99204
        • Heart Clinics Northwest
      • 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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with low/very low pre-test probability of coronary artery disease enrolled in Protocol 127-014 who did not have or were not schedule to undergo coronary angiography at the time of enrollment and did not have a clinical outcome during the initial 6 month follow-up period.

Description

Inclusion Criteria:

Patients enrolled in Protocol 127-014 who

  1. Were enrolled in Stratum 1
  2. Did not undergo angiography during study evaluation
  3. Did not have a clinical oucome during the initial 6 month follow-up period as described in Protocol 127-014.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To collect longer-term follow-up clinical information on selected patients enrolled in Protocol 127-014
Time Frame: 1 year
1 year

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

October 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 20, 2007

First Posted (Estimate)

January 2, 2008

Study Record Updates

Last Update Posted (Estimate)

July 3, 2008

Last Update Submitted That Met QC Criteria

July 1, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 127-014-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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