Quantification of Intramyocardial Lipid by Proton Magnetic Resonance Spectroscopy (MRS)
September 11, 2018 updated by: Washington University School of Medicine
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 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.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University Medical School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Magnetic Resonance Spectroscopy
Patients will have Magnetic Resonance Spectroscopy to measure in vivo accumulation of triglycerides in myocardial tissue
|
Magnetic Resonance Spectroscopy is a noninvasive procedure that provides detailed body images on any plane.
Other Names:
|
|
Experimental: Ex vivo heart biopsy
Patients will have their normal routine clinical heart biopsy of myocardial heart tissue.
|
Heart transplant patients will have their normal clinical routine heart biopsy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
2 to 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kannel WB, McGee DL. Diabetes and cardiovascular disease. The Framingham study. JAMA. 1979 May 11;241(19):2035-8. doi: 10.1001/jama.241.19.2035.
- Kannel WB, Hjortland M, Castelli WP. Role of diabetes in congestive heart failure: the Framingham study. Am J Cardiol. 1974 Jul;34(1):29-34. doi: 10.1016/0002-9149(74)90089-7. No abstract available.
- Abbott RD, Donahue RP, Kannel WB, Wilson PW. The impact of diabetes on survival following myocardial infarction in men vs women. The Framingham Study. JAMA. 1988 Dec 16;260(23):3456-60. Erratum In: JAMA 1989 Apr 7;261(13):1884.
- Koskinen P, Manttari M, Manninen V, Huttunen JK, Heinonen OP, Frick MH. Coronary heart disease incidence in NIDDM patients in the Helsinki Heart Study. Diabetes Care. 1992 Jul;15(7):820-5. doi: 10.2337/diacare.15.7.820.
- Zhou YT, Grayburn P, Karim A, Shimabukuro M, Higa M, Baetens D, Orci L, Unger RH. Lipotoxic heart disease in obese rats: implications for human obesity. Proc Natl Acad Sci U S A. 2000 Feb 15;97(4):1784-9. doi: 10.1073/pnas.97.4.1784.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
May 4, 2007
First Submitted That Met QC Criteria
May 4, 2007
First Posted (Estimate)
May 7, 2007
Study Record Updates
Last Update Posted (Actual)
September 13, 2018
Last Update Submitted That Met QC Criteria
September 11, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5P20RR02064302
- 05-0759 (Other Identifier: HRPO)
- P20RR020643 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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