Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)
Condition: Coronary Artery Disease (CAD)
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: regadenoson; overencapsulated caffeine; technetium; placebo
Intervention description: IV; oral; IV; oral
Intervention MeSH terms: Caffeine; Regadenoson
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 347.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pharmacologic stress; ischemia; coronary artery disease (CAD)

Summary:

      Observe whether the administration of caffeine prior to regadenoson will affect the
      interpretation of test results in subjects with coronary artery disease (CAD) undergoing
      SPECT MPI
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have undergone a previous diagnostic study [e.g., SPECT,
             echocardiography, magnetic resonance imaging (MRI), etc.] for a clinical indication
             demonstrating evidence of reversible defects in ≥ 1 vascular segment, have had other
             stress testing within the past 3 months, or the subject's history suggests at least a
             50% likelihood of CAD

               -  If the previous diagnostic study shows only 1 reversible defect and it is in
                  segment 17, another reversible defect will need to be present

          -  Subject with CAD must have an intermediate/low-risk for immediate intervention

          -  Subject must ingest caffeinated food or beverages regularly (at least the equivalent
             of one cup of caffeinated coffee daily)

          -  Subject must agree to not ingest any caffeine or other foods containing methylxanthine
             at least 24 hours prior to each study visit

          -  Subject must agree to abstain from eating solid food or drinking liquids other than
             water for at least 30 minutes prior to each study visit and 30 minutes following each
             study visit

        Exclusion Criteria:

          -  Subject with documented myocardial infarction (MI) ≤ 30 days prior to enrollment

          -  Subject with history of percutaneous coronary intervention (PCI) ≤ 4 weeks prior to
             enrollment

          -  Subject with history of coronary artery bypass graft (CABG) ≤ 8 weeks prior to
             enrollment

          -  Subject has prior history of heart transplantation

          -  Subject has unstable angina, known severe left main coronary artery stenosis, severe
             heart failure, uncontrolled arrhythmias, symptomatic hypotension or severe
             hypertension (systolic blood pressure < 90 or > 180 mmHg, respectively), or > 1st
             degree atrioventricular block in the absence of a functioning pacemaker

          -  Subject requires emergent cardiac medical intervention or catheterization

          -  Subject has a history of smoking, regardless of frequency, tobacco type or method of
             intake, or using any smoking cessation products, including but not limited to the
             nicotine patch or nicotine gum, within 3 months prior to first dose of regadenoson

          -  Subject is currently undergoing treatment with theophylline, or theophylline
             containing medications within 7 days prior to randomization (Day 3)

          -  Subject has a history of known or suspected bronchoconstrictive or bronchospastic lung
             disease [e.g., asthma, wheezing, chronic obstructive pulmonary disease (COPD), etc.]

          -  Subject has a history of diabetes associated with gastric disorders and/or emptying

          -  Subject has end stage renal disease (ESRD) with a GFR< 15mL/min or currently
             undergoing dialysis for ESRD