Quantification of Intramyocardial Lipid by Proton Magnetic Resonance Spectroscopy (MRS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00469911
Recruitment Status : Completed
First Posted : May 7, 2007
Last Update Posted : May 5, 2014
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Robert Gropler, Washington University School of Medicine

May 4, 2007
May 7, 2007
May 5, 2014
August 2005
June 2009   (Final data collection date for primary outcome measure)
optimizing the MRS measurement of TAG protocol devised from animal studies for respiratory and cardiac motion on a Siemens 1.5T human system [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT00469911 on Archive Site
Measure the accuracy and reproducibility of the MRS method by comparing values of myocardial TAG obtained by MRS with biochemical quantification of TAG in biopsies [ Time Frame: 2 years ]
Same as current
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Quantification of Intramyocardial Lipid by Proton Magnetic Resonance Spectroscopy
Quantification of Intramyocardial Lipid by Proton Magnetic Resonance Spectroscopy
Cardiovascular disease is the leading cause of death in patients with diabetes mellitus (DM), with atherosclerosis accounting for approximately 80% of the cases. Although the cause for the increased cardiovascular risk is multi-factorial, there is compelling evidence obtained from experimental models of DM suggesting that excessive myocardial lipid uptake may be contributory. This ectopic deposition of lipid, often stored as triacylglycerol (TAG) may directly cause myocardial damage and decreased function through a variety of mechanisms. However, accurate translation of these findings to humans with DM, requires an noninvasive imaging method that provides both accurate and reproducible measurements of myocardial tissue TAG. Currently, no such imaging method exists.
Because routine biopsy of the myocardium is not feasible, MRS is the most promising technique for the quantification of myocardial TAG. MRS is routinely used to precisely characterize metabolite concentrations in muscle and liver. 14-16 Studies such as monitoring the levels of deoxymyoglobin and real-time tracking of the postprandial accumulation of cellular lipids are examples of its diversity and potential.15,17,18 Generally, these studies suggest that the reproducibility of MRS is between 2 and 6%.18,19 In vivo cardiac MRS provides unique challenges because of the requirement to compensate for concurrent heart and lung motion. Using cardiac and respiratory gating to minimize motional artifacts, an initial validation study found a variation of 17% for sequential measurements, attributing the major error to residual motional effects. 20 Moreover, measurements were limited to the interventricular septum. Using navigator and cardiac gating appeared to give a slight, 4%, improvement, but this was a preliminary study and no validation was done.21 For a comprehensive clinical validation, other reproducibility factors must be addressed. Variations due to post-processing, coil placement and calibration, trigger reproducibility, internal versus external standard, shimming, and protocol sequence variables such as pulse quality, gradient strength, voxel size, relaxation time, echo time, and the number of scan repetitions are all known sources of reproducibility. 17,19,22-24 All of these variables must be characterized in order to achieve optimal inter- scanner and subject reproducibility along with accurate treatment tracking capability.
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Heart Transplantation
  • Procedure: Magnetic Resonance Spectroscopy
    It is basically the same as an MRI. It is a noninvasive procedure that provides detailed body images on any plane.
  • Procedure: Endocardial Biopsy
    This is a standard of care procedure that is already performed on heart transplant patients. This is a procedure that takes a biopsy (tissue sample) of the heart muscle.
    Other Name: Heart Biopsy.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2009
June 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy volunteers
  • heart transplant patients
  • undergoing post transplant endomyocardial biopsy
  • not experiencing significant rejection
  • heart transplant patients must be 18-30 years old.

Exclusion Criteria:

  • <18 or >45
  • pregnant
  • significant systemic illness
  • actively ill
  • acute transplant rejection
  • any condition that would prevent a participant from completing the NMR spectroscopy (i.e pacemakers, claustrophobia)
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
05-0759 ( Other Identifier: HRPO )
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Not Provided
Robert Gropler, Washington University School of Medicine
Washington University School of Medicine
National Institutes of Health (NIH)
Principal Investigator: Robert Gropler, MD Washington University School of Medicine
Washington University School of Medicine
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP