Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00469911
Status:
COMPLETED
Last Update Posted:
2018-09-13
First Post:
2007-05-04
Brief Title:
Quantification of Intramyocardial Lipid by Proton Magnetic Resonance Spectroscopy
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Quantification of Intramyocardial Lipid by Proton Magnetic Resonance Spectroscopy
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MRS
Brief Summary:
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
Detailed Description:
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 potential151718 Generally these studies suggest that the reproducibility of MRS is between 2 and 61819 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 done21 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 171922-24 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P20RR020643 | NIH | HRPO | httpsreporternihgovquickSearchP20RR020643 |
| 05-0759 | OTHER | None | None |