A Study to Assess Regadenoson Administration Following an Inadequate Exercise Stress Test as Compared to Regadenoson Alone for Myocardial Perfusion Imaging (MPI) Using Single Photon Emission Computed Tomography (SPECT)

Last updated: January 7, 2016
Sponsor: Astellas Pharma Global Development, Inc.
Overall Status: Completed

Phase

3

Condition

Coronary Artery Disease

Chest Pain

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT01618669
3606-CL-3004
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to demonstrate that the strength of agreement between single photon emission computed tomography (SPECT) imaging with regadenoson following inadequate exercise stress testing and SPECT imaging with regadenoson alone is not inferior to the strength of agreement between two sequential regadenoson SPECT images without exercise.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects referred for an exercise or pharmacologic stress test SPECT MPI procedure forthe evaluation of coronary artery disease (CAD) are eligible for study participation.Subjects referred for pharmacologic stress should have a reasonable potential ofattempting exercise stress. Subject must have one of the following:

  • a. Past ischemia on any prior imaging stress test without invasive interventionon the artery subtending this territory

  • b. Subject with known CAD who have symptoms similar to previous ischemicsymptoms, or recent onset of symptoms or recently worsened symptoms suggestive ofischemia

  • c. Diamond Forrester estimated pretest probability of CAD of ≥ 50%

  • d. History of most recent coronary artery bypass surgery or most recentpercutaneous coronary intervention (PCI) > 10 years (patients who are > 30 daysbut less than 10 years post coronary artery bypass graft (CABG) or PCI can beincluded if they meet criteria a, b, or e)

  • e. Previously demonstrated 100% occlusion by invasive coronary or computedtomography (CT) angiography without successful intervening revascularization asthese foods may alter regadenoson effects

Exclusion

Exclusion Criteria:

  • Subject has a clinically significant illness, medical condition, or laboratoryabnormality

  • Female subject who is pregnant or lactating

  • Subject is on dialysis for end stage renal disease or has a history of glomerularfiltration rate (GFR) < 15 mL/min (calculated using MDRD [Modification of Diet inRenal Disease] formula)

  • Subject has a history of coronary revascularization by either PCI or CABG within 1month prior to the rest myocardial perfusion imaging (MPI)

  • Subject has a pacemaker or an implantable cardioverter defibrillator (ICD)

  • Subject has a history of acute myocardial infarction (MI) or high risk unstable anginawithin 30 days prior to the rest MPI or has had cardiac transplantation

  • Subject has uncontrolled hypertension at any point on Visit 2 prior to exercisetesting (i.e., systolic blood pressure (SBP) ≥ 180 or diastolic blood pressure (DBP) ≥ 95 mmHg on two consecutive measurements while at rest).

  • Subject has severe aortic stenosis or hypertrophic cardiomyopathy with obstruction orhas decompensated congestive heart failure

  • Subject has a history of severe respiratory disease including: asthma, chronicobstructive pulmonary disease (COPD) or other bronchospastic reactive airway diseaseor who is on 24-hour continuous oxygen

Study Design

Total Participants: 1147
Study Start date:
June 01, 2012
Estimated Completion Date:
December 31, 2014

Connect with a study center

  • Hospital Italiano Garibaldi

    Rosario, Santa Fé S2000ODA
    Argentina

    Site Not Available

  • Instituto Oulton

    Cordoba, X5000JJS
    Argentina

    Site Not Available

  • Instituto de Cardiologia la Plata

    La Plata, B1925XAC
    Argentina

    Site Not Available

  • Hospital Italiano de La Plata

    Provincia de Buenos Aires, B1900AX
    Argentina

    Site Not Available

  • Sanatorio San Geronimo

    Santa Fe, S3001XAF
    Argentina

    Site Not Available

  • Clinica Anglo Americana

    Lima, Lima 27
    Peru

    Site Not Available

  • Hospital Arzobispo Loayza

    Lima,
    Peru

    Site Not Available

  • Instituto Nacional Cardiovascular de EsSalud

    Lima,
    Peru

    Site Not Available

  • VA Caribbean Healthcare System (672)

    San Juan, 00921
    Puerto Rico

    Site Not Available

  • Mobile Heart Specialists, PC

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Silicon Valley Medical Imaging

    Fremont, California 94538
    United States

    Site Not Available

  • Long Beach Memorial Medical Center

    Long Beach, California 90806
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California 90073
    United States

    Site Not Available

  • Westside Medical Associates of Los Angeles

    Los Angeles, California 90211
    United States

    Site Not Available

  • Ventura Clinical Trials

    Malibu, California 90265
    United States

    Site Not Available

  • Mission Internal Medical Group

    Mission Viejo, California 92691
    United States

    Site Not Available

  • VA San Diego Healthcare System

    San Diego, California 92161
    United States

    Site Not Available

  • Santa Rosa Cardiology Medical Group, Inc.

    Santa Rosa, California 95405
    United States

    Site Not Available

  • Los Angeles Biomedical Research Institute

    Torrance, California 22908
    United States

    Site Not Available

  • HOCC - New Britain Campus

    New Britain, Connecticut 06050
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Alfieri Cardiology

    Newark, Delaware 19713
    United States

    Site Not Available

  • Delaware Clinical Trials

    Wilmington, Delaware 19808
    United States

    Site Not Available

  • Elite Research and Clinical Trials

    Aventura, Florida 33180
    United States

    Site Not Available

  • Holy Cross Hospital

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • S & W Clinical Research

    Fort Lauderdale, Florida 33306
    United States

    Site Not Available

  • Florida Heart Associates

    Fort Myers, Florida 33907
    United States

    Site Not Available

  • East Coast Institute for Research, LLC

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • St. Luke's Cardiology St. Vincent's HealthCare

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Watson Medical Clinic/Lakeland Regional Medical Clinic

    Lakeland, Florida 33805
    United States

    Site Not Available

  • MIMA Century Research Associates

    Melbourne, Florida 32901
    United States

    Site Not Available

  • Cardiovascular Research Center of South Florida

    Miami, Florida 33173
    United States

    Site Not Available

  • Florida Hospital/Cardiovascular Institute

    Orlando, Florida 32803
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33620
    United States

    Site Not Available

  • Cardiology Partners Clinical Research Institute

    Wellington, Florida 33449
    United States

    Site Not Available

  • St. Joseph's Hospital

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • University Cardiology Associates, LLC

    Augusta, Georgia 30901
    United States

    Site Not Available

  • South Coast Medical Group

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • I U School of Medicine/ Krannert Institute of Cardiology

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Midwest Cardiology Associates

    Overland Park, Kansas 66209
    United States

    Site Not Available

  • Maine Research Associates

    Portland, Maine 04210
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21207
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Berkshire Medical Center

    Pittsfield, Massachusetts 01201
    United States

    Site Not Available

  • Henry Ford Hospital

    Detriot, Michigan 48202
    United States

    Site Not Available

  • Wayne State University

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Michigan Heart

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Hennepin County Medical Center

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Cardiology Associates of North Mississippi

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Cardiovascular Imaging Technologies

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Washington University School of Medicine

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Alegent Health Heart and Vascular Specialists

    Omaha, Nebraska 68124
    United States

    Site Not Available

  • Alegent Health Research Center

    Omaha, Nebraska 68124
    United States

    Site Not Available

  • Las Vegas Radiology

    Las Vegas, Nevada 89113
    United States

    Site Not Available

  • Laurelton Medical center

    Laurelton, New York 11422
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Westchester Medical Center-New York Medical College

    Valhalla, New York 10595
    United States

    Site Not Available

  • Buffalo Cardiology & Pulmonary Associates, P.C.

    Williamsville, New York 14221
    United States

    Site Not Available

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Berks Cardiologists, Ltd.

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Katy Cardiology Associates

    Katy, Texas 77493
    United States

    Site Not Available

  • Mission Research Institute LLC

    New Braunfels, Texas 78130
    United States

    Site Not Available

  • West Houston Area Clinical Trial Consultants, LLC

    Tomball, Texas 77375
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Roanoke Heart Institute, PC

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

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