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)
Condition: Coronary Artery Disease (CAD)
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Regadenoson; Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI)
Intervention description: Administered as an intravenous (IV) bolus
Intervention MeSH terms: Regadenoson
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronary Artery Disease (CAD); regadenoson; pharmacologic stress

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