A Study of Regadenoson in Subjects Undergoing Stress Myocardial Perfusion Imaging (MPI) Using Multidetector Computed Tomography (MDCT) Compared to Single Photon Emission Computed Tomography (SPECT)
Condition: Coronary Artery Disease (CAD)
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: regadenoson; technetium Tc99m sestamibi /technetium Tc99m tetrafosmin; Contrast; Single Photon Emission Computed Tomography; Multidetector Computed Tomography
Intervention description: Administered by intravenous bolus.; Administered by intravenous infusion; Administered by intravenous infusion.; Procedure/Surgery; Procedure/Surgery
Intervention MeSH terms: Regadenoson; Technetium Tc 99m Sestamibi
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: pharmacologic stress; Coronary Artery Disease (CAD); regadenoson; ischemia

Summary:

      The purpose of this study is to compare Multidetector Computed Tomography (MDCT) and Single
      Photon Emission Computed Tomography (SPECT) stress myocardial perfusion imaging (MPI) with
      regadenoson in order to detect the presence or absence of reversible defects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects must be ≥ 45 years of age

          -  Female subjects must be ≥ 50 years of age

          -  Subject has met at least one of the following three criteria:

               -  has a suspected (clinical impression) or known diagnosis of coronary artery
                  disease (CAD) with typical angina that has been referred from nuclear cardiology
                  lab schedule or cardiac computed tomography (CT) schedule

               -  has stable symptoms with possible elective catheterization procedure scheduled
                  and where further imaging may be beneficial;

               -  has known CAD from a previous invasive coronary angiography (ICA) performed more
                  than 12 weeks prior to screening who now present with new cardiac symptoms

          -  Subject has been referred for a clinically indicated myocardial perfusion imaging
             procedure or Cardiac CT procedure for suspected moderate or high risk CAD

          -  Subject must abstain from eating and drinking 30 minutes prior and 30 minutes post
             study drug administration

          -  Subject must abstain from smoking 3 hours prior and 8 hours post study drug
             administration

          -  Subject must abstain from any intake of methylxanthine-containing foods and beverages
             within 12 hours prior to Day 1 visit through the Day 3 Follow-Up Visit, as these foods
             may alter regadenoson effects. Subject is able to safely abstain from theophylline use
             for 12 hours prior to study drug administration

        Exclusion Criteria:

          -  Subject is concurrently participating in another drug study or has received an
             investigational drug within 30 days prior to Screening

          -  Subject has a history of a clinically significant illness (other than CAD), medical
             condition, or laboratory abnormality, which would preclude participation in the study

          -  Subject has renal dysfunction demonstrated by a glomerular filtration rate (GFR) < 45
             mL/min (calculated using Cockroft-Gault formula Note: Subjects with a GFR 45-60 mL/min
             will undergo a hydration procedure

          -  Female subject who is pregnant, lactating or of childbearing potential that refuses to
             use a medically acceptable form of contraception until the Telephone Follow up Visit
             is complete

          -  Female subject has a positive pregnancy test prior to randomization

          -  Subject has a history of second or third degree heart block or sinus node dysfunction
             unless the subject has a functioning pacemaker

          -  Subject has symptomatic hypotension (temporary and reversible conditions that no
             longer exist are allowed)

          -  Subject is allergic or intolerant to aminophylline, nitroglycerin or metoprolol

          -  Subject is allergic or intolerant to regadenoson or any of its excipients

          -  Subject is unable or unwilling to comply with the procedure schedule

          -  Subject has previously enrolled in this study or was enrolled in another regadenoson
             study sponsored by Astellas

          -  Subject has atrial fibrillation or significant arrhythmias which may result in
             decreased image quality for the imaging studies (CT and SPECT)

          -  Subject has high heart rate (> 65 beats per minute) and contra-indications to
             administer beta-blockers (severe chronic obstructive pulmonary disease (COPD) or
             asthma, second and third degree atrioventricular block)