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| ID | Type | Description | Link |
|---|---|---|---|
| 05-0759 | Other Identifier | HRPO | |
| P20RR020643 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Research Resources (NCRR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic Resonance Spectroscopy | Experimental | Patients will have Magnetic Resonance Spectroscopy to measure in vivo accumulation of triglycerides in myocardial tissue |
|
| Ex vivo heart biopsy | Experimental | Patients will have their normal routine clinical heart biopsy of myocardial heart tissue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Spectroscopy | Procedure | Magnetic Resonance Spectroscopy is a noninvasive procedure that provides detailed body images on any plane. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Co-efficient Between MRS Spectroscopy and Endomyocardial Biopsy in Heart Transplant Participants | Participants first had MRS spectroscopy then the MRS spectroscopy images were compared to endomyocardial biopsy | 2 to 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Gropler, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University Medical School | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 430798 | Background | 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. | |
| 1516498 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Heart Transplant | Compare Magnetic resonance myocardial lipid measurements with biopsy derived ex vivo measurements Magnetic Resonance Spectroscopy: It is basically the same as an MRI. It is a noninvasive procedure that provides detailed body images on any plane. 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. |
| FG001 | Controls | Normal volunteers used to assess reproducability of the MRS measurements |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Heart Transplant | Compare Magnetic resonance myocardial lipid measurements with biopsy derived ex vivo measurements Magnetic Resonance Spectroscopy: It is a noninvasive procedure that provides detailed body images on any plane. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Correlation Co-efficient Between MRS Spectroscopy and Endomyocardial Biopsy in Heart Transplant Participants | Participants first had MRS spectroscopy then the MRS spectroscopy images were compared to endomyocardial biopsy | Posted | Number | correlation co-efficient | 2 to 10 days |
|
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2 to 10 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Heart Transplant - Endomyocardial Biopsy | This is a procedure that takes a biopsy (tissue sample) of the heart muscle., and it was compared to the MRS Spectroscopy images |
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There were no limitations or caveats
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Gropler, MD, Chief of Cardiovascular Imaging Laboratory | Washington University School of Medicine | 314-747-0183 | groplerr@mir.wustl.edu |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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Compare magnetic resonance imaging measurements of triglyceride accumulation in myocardial tissue with ex vivo myocardial tissue collected from heart transplant patients who have had routine clinical heart biopsy.
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| Ex vivo heart biopsy | Procedure | Heart transplant patients will have their normal clinical routine heart biopsy |
|
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| 2974889 | Background | 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. |
| 4835750 | Background | 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. |
| 10677535 | Background | 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. |
| BG001 | Control Subjects | Control subjects with a broad range of body mass indexes and physiological conditions. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Control Subjects | Normal volunteers used to assess reproducability of the MRS measurements | 0 | 10 | 0 | 10 | 0 | 10 |
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