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Phosphorous Magnetic Resonance Spectroscopy of Heart

Primary Purpose

Left Ventricular Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MR Spectroscopy
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Left Ventricular Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals with left ventricular dysfunction

Exclusion Criteria:

  • Age < 18, pregnant, history of excessive alcohol use, or any condition (e.g. claustrophobia, a pacemaker) that would prevent him/her from completing the magnetic resonance spectroscopy study

Sites / Locations

  • Washington University in St. Louis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MR Spectroscopy Post-Heart Transplant

Arm Description

Patients post heart transplant getting heart biopsy

Outcomes

Primary Outcome Measures

An MR Spectroscopy Showing Signal to Noise Ratio to Determine the Level of Heart Failure

Secondary Outcome Measures

Full Information

First Posted
April 22, 2010
Last Updated
July 22, 2020
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01110395
Brief Title
Phosphorous Magnetic Resonance Spectroscopy of Heart
Official Title
31P Magnetic Resonance Spectroscopy of Heart
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 2009 (Actual)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Heart needs constant supply of energy to continue working. Phosphorus magnetic resonance spectroscopy allows us to measure energy produced in the heart. The purpose of this study is to determine if the energy production is reduced in failing heart.
Detailed Description
We will use non-invasive phosphorus magnetic resonance spectroscopy technique to measure creatine kinase (CK) flux in failing heart. The studies will be done on Siemens 3.0T human system. We will recruit subjects with LV dysfunction due to prior anterior wall myocardial infarction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Dysfunction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MR Spectroscopy Post-Heart Transplant
Arm Type
Experimental
Arm Description
Patients post heart transplant getting heart biopsy
Intervention Type
Diagnostic Test
Intervention Name(s)
MR Spectroscopy
Intervention Description
MR spectroscopy of myocardial
Primary Outcome Measure Information:
Title
An MR Spectroscopy Showing Signal to Noise Ratio to Determine the Level of Heart Failure
Time Frame
1-2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals with left ventricular dysfunction Exclusion Criteria: Age < 18, pregnant, history of excessive alcohol use, or any condition (e.g. claustrophobia, a pacemaker) that would prevent him/her from completing the magnetic resonance spectroscopy study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adil Bashir, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11736631
Citation
Lipskaya TY. Mitochondrial creatine kinase: properties and function. Biochemistry (Mosc). 2001 Oct;66(10):1098-111. doi: 10.1023/a:1012428812780.
Results Reference
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PubMed Identifier
8873665
Citation
Nascimben L, Ingwall JS, Pauletto P, Friedrich J, Gwathmey JK, Saks V, Pessina AC, Allen PD. Creatine kinase system in failing and nonfailing human myocardium. Circulation. 1996 Oct 15;94(8):1894-901. doi: 10.1161/01.cir.94.8.1894.
Results Reference
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PubMed Identifier
10400912
Citation
De Sousa E, Veksler V, Minajeva A, Kaasik A, Mateo P, Mayoux E, Hoerter J, Bigard X, Serrurier B, Ventura-Clapier R. Subcellular creatine kinase alterations. Implications in heart failure. Circ Res. 1999 Jul 9;85(1):68-76. doi: 10.1161/01.res.85.1.68.
Results Reference
background
PubMed Identifier
7882493
Citation
Nascimben L, Friedrich J, Liao R, Pauletto P, Pessina AC, Ingwall JS. Enalapril treatment increases cardiac performance and energy reserve via the creatine kinase reaction in myocardium of Syrian myopathic hamsters with advanced heart failure. Circulation. 1995 Mar 15;91(6):1824-33. doi: 10.1161/01.cir.91.6.1824.
Results Reference
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Phosphorous Magnetic Resonance Spectroscopy of Heart

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