Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Intervention: Regadenoson
Intervention description: Regadenoson 400 micrograms will be administered in a single IV bolus (<10 seconds) via an antecubital cannula and followed by 5 mL of saline flush. 10-20 seconds after the regadenoson is administered, 10 mCi of 13N-ammonia as a bolus, and 0.075 mmol/Kg of gadobenate dimeglumine MR contrast agent at a rate of 5 mL/sec followed by a 15 mL normal saline flush will be administered simultaneous, each into an antecubital vein, and a 15 min list-mode PET acquisition will be acquired simultaneously with the MR perfusion imaging.
Intervention MeSH terms: Regadenoson
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PET MR myocardial perfusion imaging

Summary:

      The objective for this pilot study is to develop an optimized, clinically usable myocardial
      PET-MR perfusion protocol and to determine which of all data potentially available should be
      acquired for a clinical myocardial perfusion examination. Hypothesis: The hypothesis is that
      high resolution, high sensitivity DCE MRI could replace the rest PET myocardial perfusion
      imaging, significantly decreasing examination time and patient radiation dose while
      maintaining the comprehensive reference-quality PET myocardial stress perfusion coverage.

      The primary outcome will be comparison of diagnostic accuracy of each combination of imaging
      to detect clinically significant coronary artery stenosis (≥70% diameter stenosis).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have had a clinically ordered rest/regadenoson single-isotope SPECT-MPI
             study within 10 days prior to cardiac PET-MRI examination

          -  Reversible perfusion abnormalities on SPECT imaging in at least 2 contiguous
             myocardial segments

          -  Patients for whom standard of care coronary ICA is planned

        Exclusion Criteria:

          -  An clinical event (ie; worsening angina pectoris or myocardial infarction) occuring
             after the SPECT-MPI and before the cardiac MRI examination

          -  Myocardial revascularization occuring after the SPECT-MPI and before the cardiac MRI
             examination

          -  Contraindications to MR imaging (pacemaker, brain aneurysm clips, shrapnel, etc.)

          -  Renal insufficiency (GFR < 60 mL/min/1.73m2)

          -  Allergy or other contraindication to gadolinium-based MR contrast agent

          -  Second or third degree atrioventricular (AV) block

          -  Active asthma

          -  Seizures

          -  Current hypotension (<100/60)

          -  Current hypertension (>160/90)

          -  Pregnancy

          -  Breast feeding

          -  Use of caffeine, nicotine or over the counter cold medicines within 12 hours of the
             cardiac PET-MRI examination

          -  Use of the medication dipyridamole within 48 hrs of the cardiac PET-MRI examination