Quantification of Intramyocardial Lipid by Proton Magnetic Resonance Spectroscopy

NCT00469911 | Completed Results

• 3 other identifiers: 5P20RR0206430205-0759P20RR020643
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Transplantation

Keywords

Heart; Transplant; MRS; MRI; Spectroscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Magnetic Resonance Spectroscopy

EXPERIMENTAL

Patients will have Magnetic Resonance Spectroscopy to measure in vivo accumulation of triglycerides in myocardial tissue

Procedure: Magnetic Resonance Spectroscopy

Ex vivo heart biopsy

EXPERIMENTAL

Patients will have their normal routine clinical heart biopsy of myocardial heart tissue.

Procedure: Ex vivo heart biopsy

Interventions

Magnetic Resonance Spectroscopy PROCEDURE

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

Also known as: MRS

Magnetic Resonance Spectroscopy

Ex vivo heart biopsy PROCEDURE

Heart transplant patients will have their normal clinical routine heart biopsy

Also known as: heart biopsy

Ex vivo heart biopsy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteers
• heart transplant patients
• undergoing post transplant endomyocardial biopsy
• not experiencing significant rejection
• heart transplant patients must be 18-30 years old.

You may not qualify if:

• \<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)

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institutes of Health (NIH): collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Washington University Medical School

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

• 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.

  PMID: 430798 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.

  PMID: 1516498 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.

  PMID: 2974889 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.

  PMID: 4835750 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.

  PMID: 10677535 BACKGROUND

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

There were no limitations or caveats

Results Point of Contact

• Title: Robert Gropler, MD, Chief of Cardiovascular Imaging Laboratory
• Organization: Washington University School of Medicine

groplerr@mir.wustl.edu

314-747-0183

Study Officials

• Robert Gropler, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2007
• First Posted: May 7, 2007
• Study Start: August 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 13, 2018
• Results First Posted: September 13, 2018

Record last verified: 2018-09

Locations

US (1)