N/A
N=18
Quantification of Intramyocardial Lipid by Proton Magnetic Resonance Spectroscopy
Heart Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00469911 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Correlation Co-efficient Between MRS Spectroscopy and Endomyocardial Biopsy in Heart Transplant Participants — 0.97 correlation co-efficient — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Magnetic Resonance Spectroscopy (Procedure); Ex vivo heart biopsy (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Co-efficient Between MRS Spectroscopy and Endomyocardial Biopsy in Heart Transplant Participants |
0.97 | <0.05 sig |
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.
Eligibility Criteria
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
- 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)
Data sourced from ClinicalTrials.gov (NCT00469911). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.