Distribution of Rubidium-82, Nitrogen-13 Ammonia, and Fluorine-18 Fluorodeoxyglucose in Normal Volunteers
Condition: Heart Disease
MeSH terms: Heart Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Establish the normal distributions of Rb-82, N-13 ammonia, and F-18 FDG (radioactive tracers)
      in the heart using PET imaging. These tracers would be eventually used in evaluating the
      hearts of patients with heart disease.

      Normal healthy volunteers will be carefully screened for this study. Subjects will be given
      IV administration of Rb-82 and N-13 to acquire rest/stress imaging. Normal subjects not
      excluded by any unexpected abnormality during the Rb-82 or N-13 rest/stress studies will
      undergo a glucose loading F-18 FDG imaging protocol, viability protocol using the
      hyperinsulinemic euglycemic clamp with simultaneous IV infusions of dextrose and insulin
      according to standard procedures in our laboratory.

      These same subjects will have a F-18 FDG protocol after following a high fat, protein
      permitted, no carbohydrate diet for approximately 30 hours prior to F-18 FDG injection. The
      F-18 FDG radiotracer will be given through an IV.
    

Detailed description: 
      Cardiac rubidium-82(Rb-82)and N-13 ammonia heart perfusion (blood flow) studies and
      florine-18 fluorodeoxyglucose (F-18FDG) heart PET glucose metabolism studies are important
      tools for evaluating patients with coronary heart disease.

      This includes patients with known or suspected heart disease and patients with congestive
      heart failure following myocardial infarction (heart attack) with indeterminant assessments
      of cardiac health from other types of imaging, such as SPECT perfusion imaging and
      echocardiography.

      These studies help physicians plan potentially life saving procedures to re-establish
      coronary blood flow to living but severely compromised heart muscle. Rb-82 and N-13 ammonia
      studies can tell if there is reduced blood flow to the heart muscle either at rest or during
      stress.

      FDG studies can tell whether there is any chance of a beneficial effect from coronary
      revascularization procedures, for example coronary angioplasties and stents or coronary
      artery bypass. Revascularization procedures in patients like these may be technically
      difficult, risky and costly.

      Unfortunately the normal cardiac distributions of Rb-82, N-13 and ammonia, and F-18FDG for
      computer analysis of human studies are not well known and what is known is not widely
      available for clinical use. The latest imaging guidelines from the American Society of
      Nuclear Cardiology recommend that Rb-82, N-13 ammonia, and FDG cardiac studies be compared to
      normal distributions or patterns of these radiotracers in the heart developed from a series
      of normal individuals.

      The purpose for these studies is to generate databases of normal Rb-82, N-13 ammonia, and
      F-18FDG cardiac distributions so that they can be used in the analysis of clinical patient
      studies at the University of Michigan Hospital.
    

Intervention name(s): Rb-82 Pet scans; F-18 FDG Pet scans; N-13 ammonia Pet scans; Regadenoson
Intervention type(s): Other; Other; Other; Drug
Intervention description(s): Intravenous administration of Rb-82. Images will be taken according to standard clinical imaging protocol and reviewed. Patient will be connected to an EKG machine to monitor the heart. Blood pressure will be monitored as well. For Rb-82 images, 40 mCi (millicuries are a measurement of radioactivity) will be used. Acquisition time for both rest and stress studies should take about 30 min.; Volunteers undergoing the F-18 FDG protocols will undergo: (1) glucose loading protocol for "viability protocol imaging" with the hyperinsulinemic euglycemic clamp according to standard procedures in our laboratory, and (2) "inflammation protocol imaging" using a high fat preparatory diet and three sub-therapeutic heparin doses (10 units / kg each) according to standard laboratory procedure. When metabolically prepared with the viability protocol and the inflammation protocol (two separate days), 10 mCi (millicuries) of F-18 FDG will be administered IV per FDG protocols, via heparin lock. 40-60 minutes after FDG injections PET imaging will be performed according to standard clinical imaging protocol.; Intravenous administration of N-13. Images will be taken according to standard clinical imaging protocol and reviewed. Patient will be connected to an EKG machine to monitor the heart. Blood pressure will be monitored as well. For N-13 ammonia images, 20 mCi (millicuries) will be used. Acquisition time for both rest and stress studies should take about 30 min.; Regadenoson is used as a stressor; but not to study its effects.
Intervention MeSH terms: Regadenoson
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will have a PET scan after IV administration of a radio-labelled tracer, Rb-82 and N-13 or injection of F-18 FDG
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: heart; perfusion; glucose