An interventional study of Magnetic Resonance Spectroscopy and Ex vivo heart biopsy in Heart Transplantation, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-13.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Diagnostic
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.
Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
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Exclusion Criteria:
Patients will have Magnetic Resonance Spectroscopy to measure in vivo accumulation of triglycerides in myocardial tissue
Procedure: Magnetic Resonance Spectroscopy
Patients will have their normal routine clinical heart biopsy of myocardial heart tissue.
Procedure: Ex vivo heart biopsy
Magnetic Resonance Spectroscopy is a noninvasive procedure that provides detailed body images on any plane.
Also known as: MRS
Heart transplant patients will have their normal clinical routine heart biopsy
Also known as: heart biopsy
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
Time frame: 2 to 10 days
| Milestone | Heart Transplant | Controls |
|---|---|---|
| Started | 8 | 10 |
| Completed | 8 | 10 |
| Not completed | 0 | 0 |
Participants first had MRS spectroscopy then the MRS spectroscopy images were compared to endomyocardial biopsy
| correlation co-efficient | Heart Transplant Patients |
|---|---|
| Correlation Co-efficient Between MRS Spectroscopy and Endomyocardial Biopsy in Heart Transplant Participants | 0.97 |
Collected over 2 to 10 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Heart Transplant - Endomyocardial Biopsy | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Control Subjects | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Heart Transplant | Control Subjects | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 10 | 18 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Heart Transplant | Control Subjects | Total |
|---|---|---|---|
| Female | 5 | 5 | 10 |
| Male | 3 | 5 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Heart Transplant | Control Subjects | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 8 | 10 | 18 |
| Race (NIH/OMB)(Participants) | Heart Transplant | Control Subjects | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 8 | 10 | 18 |
| Region of Enrollment(Participants) | Heart Transplant | Control Subjects | Total |
|---|---|---|---|
| United States | 8 | 10 | 18 |
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