A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.

Last updated: November 6, 2020
Sponsor: Lantheus Medical Imaging
Overall Status: Completed

Phase

3

Condition

Myocardial Ischemia

Coronary Artery Disease

Chest Pain

Treatment

N/A

Clinical Study ID

NCT01347710
BMS747158-301
  • Ages > 18
  • All Genders

Study Summary

The primary objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to single photon emission computed tomography (SPECT) MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a documented history of Myocardial Infarction (MI).

Eligibility Criteria

Inclusion

Inclusion Criteria: Invasive Coronary Angiography. Men or Women age 18 or older - see protocol for additionaldetails.

Exclusion

Exclusion Criteria: Women who are pregnant, lactating, or of child bearing potential who are not practicingbirth control. Unstable cardiac status. History of coronary artery bypass graft. History of percutaneouscoronary intervention within the past six months. See protocol for additional details.

Study Design

Total Participants: 795
Study Start date:
June 01, 2011
Estimated Completion Date:
September 30, 2013

Study Description

The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz F18 Injection MPI against SPECT MPI in patients screened for CAD as determined by ICA. Six hundred and eighty evaluable patients will be enrolled and will undergo SPECT MPI and Flurpiridaz F18 PET MPI. Patients will be considered for enrollment if they are scheduled to undergo or have undergone prior ICA without intervention (being either positive or negative for CAD).

Connect with a study center

  • University of Western Ontario

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • KMH Cardiology and Diagnostic and MRI Centres

    Mississauga, Ontario L5K 2L3
    Canada

    Site Not Available

  • University of Ottawa Heart Institute

    Ottawa, Ontario K1Y 4W7
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire de Sherbrooke (CHUS)

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • Helsinki University Hospital

    Helsinki, 00029 HUS
    Finland

    Site Not Available

  • Turku PET Centre

    Turku, FI-20520
    Finland

    Site Not Available

  • San Patricio MEDFLIX (San Patricio MRI & CT Center)

    Guaynabo, 00968
    Puerto Rico

    Site Not Available

  • VA Caribbean Healthcare System

    San Juan, 00921
    Puerto Rico

    Site Not Available

  • Cardiology Associates of Mobile, Inc.

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Scottsdale Medical Imaging, Ltd.

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • West Side Medical Associates of Los Angeles

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • USC PET Imaging Science Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • VA West Los Angeles Medical Center

    Los Angeles, California 90073
    United States

    Site Not Available

  • Veterans Affairs Palo Alto Health Care System

    Palo Alto, California 94304
    United States

    Site Not Available

  • Cardiovascular Consultants Medical Group

    Pleasant Hill, California 94523
    United States

    Site Not Available

  • Northern California PET Imaging Center-Palo Alto

    Sacramento, California 95816
    United States

    Site Not Available

  • Northern California PET Imaging Center-Palo Alto

    Sacremento, California 95816
    United States

    Site Not Available

  • VA San Diego Healthcare System

    San Diego, California 92161
    United States

    Site Not Available

  • UCSF Medical Center

    San Francisco, California 94107
    United States

    Site Not Available

  • Cardiology Consultants Medical Group

    Tarzana, California 91356
    United States

    Site Not Available

  • Westlake Medical Research

    Westlake Village, California 91361
    United States

    Site Not Available

  • Danbury Hospital

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Alfieri Cardiology

    Newark, Delaware 19713
    United States

    Site Not Available

  • Christiana Care Health System

    Newark, Delaware 19718
    United States

    Site Not Available

  • Elite Research and Clinical Trials

    Aventura, Florida 33180
    United States

    Site Not Available

  • Independent Imaging, LLC

    Boynton Beach, Florida 33437
    United States

    Site Not Available

  • Coastal Cardiology Consultants dba The Heart & Vascular Institute of Florida

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Florida Heart Associates

    Fort Myers, Florida 33907
    United States

    Site Not Available

  • St. Luke's Cardiology Associates

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • The Cardiovascular Center, PA

    Lake Mary, Florida 32746
    United States

    Site Not Available

  • Florida Hospital/Cardiovascular Institute (Florida Heart Group)

    Orlando, Florida 32803
    United States

    Site Not Available

  • South Florida Research Solutions

    Pembroke Pines, Florida 33028
    United States

    Site Not Available

  • Memorial Hospital of Tampa

    Tampa, Florida 33609
    United States

    Site Not Available

  • Georgia Health Sciences Univ/Med College of GA

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Cardiovascular Group, P.C.

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • South Coast Imaging Center

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Gateway Cardiology, PC

    Jerseyville, Illinois 62052
    United States

    Site Not Available

  • Norton Cardiovascular Associates

    Louisville, Kentucky 40205-3372
    United States

    Site Not Available

  • Biomedical Research Foundation of Northwest Louisiana

    Shreveport, Louisiana 71133-8050
    United States

    Site Not Available

  • Maine Research Associates

    Auburn, Maine 04210
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21287-0817
    United States

    Site Not Available

  • Boston University Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Mass General Hospital (MGH)

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • St. Elizabeth's Medical Center

    Brighton, Massachusetts 02135
    United States

    Site Not Available

  • University of Michigan Health System

    Ann Arbor, Michigan 48109-5873
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Wayne State University - Harper University Hospital

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Michigan State University

    East Lansing, Michigan 48824
    United States

    Site Not Available

  • St. Mary's Healthcare (Trinity Health)

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • McLaren Macomb

    Mount Clemens, Michigan 48043
    United States

    Site Not Available

  • William Beaumont Hospital

    Royal Oak, Michigan 48073-6769
    United States

    Site Not Available

  • Hattiesburg Clinic

    Hattiesburg, Mississippi 39401
    United States

    Site Not Available

  • Missouri Cardiovascular Specialists, LLP

    Columbia, Missouri 65201
    United States

    Site Not Available

  • Cardiovascular Imaging Technologies (CVIT)

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Saint Louis University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Saint Louis University School of Medicine

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Las Vegas Radiology

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Mount Sinai Medical Center

    New York, New York 10029
    United States

    Site Not Available

  • St. Francis Hospital

    Roslyn, New York 11576
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • University of Cincinnati Physicians Company

    Cincinnatti, Ohio 45219
    United States

    Site Not Available

  • OhioHealth Research Institute

    Columbus, Ohio 43214
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Kettering Medical Center

    Kettering, Ohio 45429
    United States

    Site Not Available

  • Pinnacle Health Cardiovascular Institute/ Associated Cardiologists

    Harrisburg, Pennsylvania 17110
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Presbyterian University Hospital

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Berks Cardiologists, Ltd.

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • York Hospital /Wellspan Health

    York, Pennsylvania 17405
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Mountain States Health Alliance

    Johnson City, Tennessee 37604
    United States

    Site Not Available

  • Wellmont CVA Heart Institute

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Cardiovascular Research of Knoxville - St. Mary's Health Care System, Inc.

    Knoxville, Tennessee 37917
    United States

    Site Not Available

  • Center for Biomedical Research

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Vanderbilt Heart and Vascular Institute

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Dallas VA Medical Center

    Dallas, Texas 75216
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston, Texas 77555-0709
    United States

    Site Not Available

  • Excel Diagnostics and Nuclear Oncology Center

    Houston, Texas 77042
    United States

    Site Not Available

  • Katy Cardiology

    Katy, Texas 77493
    United States

    Site Not Available

  • West Houston Area Clinical Trial Consultants, LLC

    Tomball, Texas 77375
    United States

    Site Not Available

  • University of Virginia Health System

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • McGuire Veteran Affairs Medical Center

    Richmond, Virginia 23249
    United States

    Site Not Available

  • Carilion Cardiology Clinic

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • Roanoke Heart Institute

    Roanoke, Virginia 24014
    United States

    Site Not Available

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