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)
NCT ID: NCT01618669
Last Updated: 2016-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1147 participants
INTERVENTIONAL
2012-06-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Regadenoson After Peak Exercise
On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
Regadenoson
Administered as an intravenous (IV) bolus
Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI)
Regadenoson Alone
On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus (1 hour after exercise recovery), and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
Regadenoson
Administered as an intravenous (IV) bolus
Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI)
Interventions
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Regadenoson
Administered as an intravenous (IV) bolus
Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* a. Past ischemia on any prior imaging stress test without invasive intervention on the artery subtending this territory
* b. Subject with known CAD who have symptoms similar to previous ischemic symptoms, or recent onset of symptoms or recently worsened symptoms suggestive of ischemia
* c. Diamond Forrester estimated pretest probability of CAD of ≥ 50%
* d. History of most recent coronary artery bypass surgery or most recent percutaneous coronary intervention (PCI) \> 10 years (patients who are \> 30 days but less than 10 years post coronary artery bypass graft (CABG) or PCI can be included if they meet criteria a, b, or e)
* e. Previously demonstrated 100% occlusion by invasive coronary or computed tomography (CT) angiography without successful intervening revascularization as these foods may alter regadenoson effects
Exclusion Criteria
* Female subject who is pregnant or lactating
* Subject is on dialysis for end stage renal disease or has a history of glomerular filtration rate (GFR) \< 15 mL/min (calculated using MDRD \[Modification of Diet in Renal Disease\] formula)
* Subject has a history of coronary revascularization by either PCI or CABG within 1 month 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 angina within 30 days prior to the rest MPI or has had cardiac transplantation
* Subject has uncontrolled hypertension at any point on Visit 2 prior to exercise testing (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 or has decompensated congestive heart failure
* Subject has a history of severe respiratory disease including: asthma, chronic obstructive pulmonary disease (COPD) or other bronchospastic reactive airway disease or who is on 24-hour continuous oxygen
18 Years
ALL
No
Sponsors
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Astellas Pharma Global Development, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development, Inc.
Locations
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Mobile Heart Specialists, PC
Mobile, Alabama, United States
Silicon Valley Medical Imaging
Fremont, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
Westside Medical Associates of Los Angeles
Los Angeles, California, United States
Ventura Clinical Trials
Malibu, California, United States
Mission Internal Medical Group
Mission Viejo, California, United States
VA San Diego Healthcare System
San Diego, California, United States
Santa Rosa Cardiology Medical Group, Inc.
Santa Rosa, California, United States
Los Angeles Biomedical Research Institute
Torrance, California, United States
HOCC - New Britain Campus
New Britain, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Alfieri Cardiology
Newark, Delaware, United States
Delaware Clinical Trials
Wilmington, Delaware, United States
Elite Research and Clinical Trials
Aventura, Florida, United States
S & W Clinical Research
Fort Lauderdale, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Florida Heart Associates
Fort Myers, Florida, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
St. Luke's Cardiology St. Vincent's HealthCare
Jacksonville, Florida, United States
Watson Medical Clinic/Lakeland Regional Medical Clinic
Lakeland, Florida, United States
MIMA Century Research Associates
Melbourne, Florida, United States
Cardiovascular Research Center of South Florida
Miami, Florida, United States
Florida Hospital/Cardiovascular Institute
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, United States
St. Joseph's Hospital
Atlanta, Georgia, United States
University Cardiology Associates, LLC
Augusta, Georgia, United States
South Coast Medical Group
Savannah, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
I U School of Medicine/ Krannert Institute of Cardiology
Indianapolis, Indiana, United States
Midwest Cardiology Associates
Overland Park, Kansas, United States
Maine Research Associates
Portland, Maine, United States
University of Maryland
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Berkshire Medical Center
Pittsfield, Massachusetts, United States
Henry Ford Hospital
Detriot, Michigan, United States
Wayne State University
Detroit, Michigan, United States
Michigan Heart
Ypsilanti, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Cardiology Associates of North Mississippi
Tupelo, Mississippi, United States
Cardiovascular Imaging Technologies
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Alegent Health Heart and Vascular Specialists
Omaha, Nebraska, United States
Alegent Health Research Center
Omaha, Nebraska, United States
Las Vegas Radiology
Las Vegas, Nevada, United States
Laurelton Medical center
Laurelton, New York, United States
Columbia University Medical Center
New York, New York, United States
Westchester Medical Center-New York Medical College
Valhalla, New York, United States
Buffalo Cardiology & Pulmonary Associates, P.C.
Williamsville, New York, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Berks Cardiologists, Ltd.
Wyomissing, Pennsylvania, United States
Katy Cardiology Associates
Katy, Texas, United States
Mission Research Institute LLC
New Braunfels, Texas, United States
West Houston Area Clinical Trial Consultants, LLC
Tomball, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Roanoke Heart Institute, PC
Roanoke, Virginia, United States
University of Washington
Seattle, Washington, United States
Hospital Italiano Garibaldi
Rosario, Santa Fe Province, Argentina
Instituto Oulton
Córdoba, , Argentina
Instituto de Cardiologia la Plata
La Plata, , Argentina
Hospital Italiano de La Plata
Provincia de Buenos Aires, , Argentina
Sanatorio San Geronimo
Santa Fe, , Argentina
Clinica Anglo Americana
Lima, , Peru
Hospital Arzobispo Loayza
Lima, , Peru
Instituto Nacional Cardiovascular de EsSalud
Lima, , Peru
VA Caribbean Healthcare System (672)
San Juan, , Puerto Rico
Countries
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References
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Thomas GS, Cullom SJ, Kitt TM, Feaheny KM, Ananthasubramaniam K, Gropler RJ, Jain D, Thompson RC. The EXERRT trial: "EXErcise to Regadenoson in Recovery Trial": A phase 3b, open-label, parallel group, randomized, multicenter study to assess regadenoson administration following an inadequate exercise stress test as compared to regadenoson without exercise for myocardial perfusion imaging using a SPECT protocol. J Nucl Cardiol. 2017 Jun;24(3):788-802. doi: 10.1007/s12350-017-0813-3. Epub 2017 Feb 21.
Related Links
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Link to results on Astellas Clinical Study Results Web site
Other Identifiers
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3606-CL-3004
Identifier Type: -
Identifier Source: org_study_id
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