Clinical trial NCT01618669: 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)
Official title: A Phase 3b, Open-Label, Parallel Group, Randomized, Multicenter 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease (CAD)
Keywords: Coronary Artery Disease (CAD)
regadenoson
pharmacologic stress
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-06-13
Enrollment: 1147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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 Criteria:

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

  * 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:

* Subject has a clinically significant illness, medical condition, or laboratory abnormality
* 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

Primary outcomes:
measure: Proportion of Participants With Majority Reader Self-agreement in Ischemia Assessment Between First and Second Stress Scans
timeFrame: Day 1 (rest scan and first stress scan) and Day 2 -15 (second stress scan)
Secondary outcomes:
measure: Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events
timeFrame: Within 1 hour for ECG events and up to 24 hours for adverse events after administration of regadenoson
measure: Proportion of Participants With Agreement in the Assessment of Absence or Presence of Ischemia Between First and Second Stress Scans
timeFrame: Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2)
measure: Proportion of Participants With Agreement in the Assessment of Reversible Defects in 3 Categories of Ischemia Between First and Second Stress Scans
timeFrame: Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)
measure: Proportion of Participants With Agreement in the Summed Stress Score (SSS) Between First and Second Stress Scans
timeFrame: Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)
measure: Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans
timeFrame: Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2)
measure: Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan
timeFrame: Day 1 (stress MPI 1) and Day 2-15 (stress MPI 2)
measure: Overall Assessment of Image Quality
timeFrame: Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2)
measure: Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans
timeFrame: Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)
measure: Percentage of Scans With Subdiaphragmatic Interference
timeFrame: Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2)
measure: Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity
timeFrame: Day 1 (stress MPI 1) and Day - 15 (stress MPI 2)
measure: Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson
timeFrame: Up to 24 hours after study drug administration for each stress MPI (Day 1 and Day 2-15)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mobile Heart Specialists, PC
state: Alabama
city: Fremont
country: United States
facility: Silicon Valley Medical Imaging
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Los Angeles
country: United States
facility: Westside Medical Associates of Los Angeles
state: California
city: Malibu
country: United States
facility: Ventura Clinical Trials
state: California
city: Mission Viejo
country: United States
facility: Mission Internal Medical Group
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: Santa Rosa
country: United States
facility: Santa Rosa Cardiology Medical Group, Inc.
state: California
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute
state: California
city: New Britain
country: United States
facility: HOCC - New Britain Campus
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Newark
country: United States
facility: Alfieri Cardiology
state: Delaware
city: Wilmington
country: United States
facility: Delaware Clinical Trials
state: Delaware
city: Aventura
country: United States
facility: Elite Research and Clinical Trials
state: Florida
city: Fort Lauderdale
country: United States
facility: S & W Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Fort Myers
country: United States
facility: Florida Heart Associates
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: St. Luke's Cardiology St. Vincent's HealthCare
state: Florida
city: Lakeland
country: United States
facility: Watson Medical Clinic/Lakeland Regional Medical Clinic
state: Florida
city: Melbourne
country: United States
facility: MIMA Century Research Associates
state: Florida
city: Miami
country: United States
facility: Cardiovascular Research Center of South Florida
state: Florida
city: Orlando
country: United States
facility: Florida Hospital/Cardiovascular Institute
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Wellington
country: United States
facility: Cardiology Partners Clinical Research Institute
state: Florida
city: Atlanta
country: United States
facility: St. Joseph's Hospital
state: Georgia
city: Augusta
country: United States
facility: University Cardiology Associates, LLC
state: Georgia
city: Savannah
country: United States
facility: South Coast Medical Group
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: I U School of Medicine/ Krannert Institute of Cardiology
state: Indiana
city: Overland Park
country: United States
facility: Midwest Cardiology Associates
state: Kansas
city: Portland
country: United States
facility: Maine Research Associates
state: Maine
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Pittsfield
country: United States
facility: Berkshire Medical Center
state: Massachusetts
city: Detriot
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Tupelo
country: United States
facility: Cardiology Associates of North Mississippi
state: Mississippi
city: Kansas City
country: United States
facility: Cardiovascular Imaging Technologies
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: Alegent Health Heart and Vascular Specialists
state: Nebraska
city: Omaha
country: United States
facility: Alegent Health Research Center
state: Nebraska
city: Las Vegas
country: United States
facility: Las Vegas Radiology
state: Nevada
city: Laurelton
country: United States
facility: Laurelton Medical center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center-New York Medical College
state: New York
city: Williamsville
country: United States
facility: Buffalo Cardiology & Pulmonary Associates, P.C.
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Cardiologists, Ltd.
state: Pennsylvania
city: Katy
country: United States
facility: Katy Cardiology Associates
state: Texas
city: New Braunfels
country: United States
facility: Mission Research Institute LLC
state: Texas
city: Tomball
country: United States
facility: West Houston Area Clinical Trial Consultants, LLC
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Roanoke
country: United States
facility: Roanoke Heart Institute, PC
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Rosario
country: Argentina
facility: Hospital Italiano Garibaldi
state: Santa Fé
city: Cordoba
country: Argentina
facility: Instituto Oulton
city: La Plata
country: Argentina
facility: Instituto de Cardiologia la Plata
city: Provincia de Buenos Aires
country: Argentina
facility: Hospital Italiano de La Plata
city: Santa Fe
country: Argentina
facility: Sanatorio San Geronimo
city: Lima
country: Peru
facility: Clinica Anglo Americana
city: Lima
country: Peru
facility: Hospital Arzobispo Loayza
city: Lima
country: Peru
facility: Instituto Nacional Cardiovascular de EsSalud
city: San Juan
country: Puerto Rico
facility: VA Caribbean Healthcare System (672)
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Senior Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.