Absolute Quantification of Coronary Flow Reserve by Stress Perfusion MRI
Condition: Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Ischemia
Intervention: Regadenoson; gadofoveset trisodium
Intervention description: Regadenoson will be infused intravenously 0.4 mg/5 mL (0.08 mg/mL) as a single bolus.; All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar) at both stress and rest.
Intervention MeSH terms: Regadenoson
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: Single
Enrollment: 20.0
Sex: All
Minimum age: 19 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Magnetic Resonance Imaging; regadenoson

Summary:

      Coronary artery disease (CAD, coronary heart disease) is the leading cause of death in the
      U.S., causing 1 in 5 deaths in 2005. The current method for diagnosing coronary artery
      disease that is considered most accurate is coronary angiography however it involves risk and
      radiation. Alternatively nuclear imaging test and MRI stress test only permits the semi
      qualitative analysis of the myocardial perfusion images.

      In this proposal the investigators will develop a means to calculate Coronary Flow Reserve
      (CFR) using the MRI. the investigators approach has the potential to reduce mortality from
      myocardial infarction by effecting a change in the patient management paradigm. Absolute
      quantification of myocardial perfusion will detect coronary stenosis and CAD in patients with
      more accuracy than the semi-quantitative or qualitative analysis of perfusion images.
      Measurement of Coronary Flow Reserve is important for the following reasons: decrease of
      coronary flow reserve has been identified as a first effect of CAD; it provides an objective
      measure of treatment efficacy.

      The purpose of this study is to compare images from nuclear stress test and/or coronary
      angiography with Magnetic Resonance Imaging (MRI) that will evaluate subjects with coronary
      artery disease calculating myocardial blood flow using a novel MRI technique combined to an
      extracellular Gadolinium-based contrast agent and stressor agent
    

Eligibility criteria:

        Inclusion Criteria:

        Under an Institutional Committee on Human Research board approved protocol, 20 patients
        with a suspected myocardial ischemic disease with positive stress nuclear medicine test
        laboratory will be recruited in this prospective study. All subjects will be screened for
        GFR within 24 hours before the exam. All patients must have a GFR > 30 mL/min/1.73m2 to be
        included in the study.

        All subjects will be selected following the Nephrogenic Systemic Fibrosis (NSF) guidelines.
        All dialysis patients or end-stage renal disease patients with a creatinine clearance of <
        30mL/min will not be selected for the study to avoid NSF.

        Exclusion Criteria:

          1. Age 18 to 89 years;

          2. Known contraindication to MR imaging (such as pacemaker placement, magnetic implants,
             etc);

          3. Claustrophobia;

          4. Inability to perform an adequate breath-hold for imaging,

          5. Inability to provide informed consent;

          6. all subjects will be will be screened for GFR within 24 hours before the exam and
             subjects presenting with GFR < 60 ml/min will be excluded;

          7. Pregnant and lactating women;

          8. Patients with hypersensitivity to gadolinium contrast agents, metoprolol, adenosine,
             or nitroglycerin;

        10) Contra indication for Regadenoson

          1. 2nd- or 3rd-degree AV block (except in patients with a functioning artificial
             pacemaker)

          2. Sinus node disease (except in patients with a functioning artificial pacemaker)

          3. Unstable angina

          4. Acute myocardial infarction

          5. Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma)

          6. Hypersensitivity to adenosine

          7. Caffeine within 12-24 hours

          8. Theophylline and Dipyridamole products within 24 hours