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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00469911
First received: May 4, 2007
Last updated: February 9, 2010
Last verified: February 2010

May 4, 2007
February 9, 2010
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00469911 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
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)
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00469911
5P20RR02064302, 05-0759
No
Robert Gropler, MD, Washington University in St Louis
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
February 2010

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