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Quantification of Intramyocardial Lipid by Proton Magnetic Resonance Spectroscopy

Quantification of Intramyocardial Lipid by Proton Magnetic Resonance Spectroscopy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00469911
Acronym
MRS
Enrollment
18
Registered
2007-05-07
Start date
2005-08-31
Completion date
2009-06-30
Last updated
2018-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplantation

Keywords

Heart, Transplant, MRS, MRI, Spectroscopy

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 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.

Interventions

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

PROCEDUREEx vivo heart biopsy

Heart transplant patients will have their normal clinical routine heart biopsy

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Center for Research Resources (NCRR)
CollaboratorNIH
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Correlation Co-efficient Between MRS Spectroscopy and Endomyocardial Biopsy in Heart Transplant Participants2 to 10 daysParticipants first had MRS spectroscopy then the MRS spectroscopy images were compared to endomyocardial biopsy

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
8
Control Subjects
Control subjects with a broad range of body mass indexes and physiological conditions.
10
Total18

Baseline characteristics

CharacteristicHeart TransplantControl SubjectsTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
8 Participants10 Participants18 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
8 Participants10 Participants18 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants10 Participants18 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
8 Participants10 Participants18 Participants
Sex: Female, Male
Female
5 Participants5 Participants10 Participants
Sex: Female, Male
Male
3 Participants5 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 80 / 10
other
Total, other adverse events
0 / 80 / 10
serious
Total, serious adverse events
0 / 80 / 10

Outcome results

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

Time frame: 2 to 10 days

ArmMeasureValue (NUMBER)
Heart Transplant PatientsCorrelation Co-efficient Between MRS Spectroscopy and Endomyocardial Biopsy in Heart Transplant Participants0.97 correlation co-efficient
p-value: <0.05t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026