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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00469911
First Posted: May 7, 2007
Last Update Posted: May 5, 2014
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.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Robert Gropler, Washington University School of Medicine
  Purpose
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.

Condition Intervention
Heart Transplantation Procedure: Magnetic Resonance Spectroscopy Procedure: Endocardial Biopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantification of Intramyocardial Lipid by Proton Magnetic Resonance Spectroscopy

Resource links provided by NLM:


Further study details as provided by Robert Gropler, Washington University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: August 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469911


Locations
United States, Missouri
Washington University Medical School
St Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
Investigators
Principal Investigator: Robert Gropler, MD Washington University School of Medicine