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Completed

NCT Number: NCT00469911

Quantification of Intramyocardial Lipid by Proton Magnetic Resonance Spectroscopy

Accumulation of triglycerides in heart tissue has been associated with changes in left ventricular function which can lead to heart failure. Proton magnetic resonance spectroscopy is currently the only non-invasive in vivo method to measure myocardial triglycerides content. The primary goal of this study was to determine if Magnetic Resonance Spectroscopy could effectively measure myocardial triglyceride content in myocardial heart tissue. Thus, quantitative and reliable techniques to monitor in vivo triglyceride accumulation in the heart are important for disease diagnosis and management. Currently, no such imaging method exists.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University Medical School

St Louis, Missouri, 63110, United States

About this study

Because routine biopsy of the myocardium is not feasible, MRS is the most promising technique for the quantification of myocardial triglycerides. 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 inter-ventricular 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. Therefore, 10 normal healthy volunteers were imaged to determine the reliability of the MRS protocol with test-re-test measurements. The 8 heart transplant patients were imaged prior to their routine heart biopsies, and then the myocardial biopsy tissue was measure and compared to the pre-biopsy images.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Magnetic Resonance Spectroscopy

Procedure

Magnetic Resonance Spectroscopy is a noninvasive procedure that provides detailed body images on any plane.

Other names: MRS

Ex vivo heart biopsy

Procedure

Heart transplant patients will have their normal clinical routine heart biopsy

Other names: heart biopsy

Primary outcomes

  1. Correlation Co-efficient Between MRS Spectroscopy and Endomyocardial Biopsy in Heart Transplant Participants

    Time frame: 2 to 10 days

    Participants first had MRS spectroscopy then the MRS spectroscopy images were compared to endomyocardial biopsy

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Center for Research Resources (NCRR)
  • National Institutes of Health (NIH)

Registry information

Acronym: MRS

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
May 7, 2007
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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