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Phosphorous Magnetic Resonance Spectroscopy of Heart

This study is currently recruiting participants.
Verified December 2012 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Adil Bashir, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01110395
First received: April 22, 2010
Last updated: December 19, 2012
Last verified: December 2012
History of Changes

April 22, 2010
December 19, 2012
June 2009
June 2015   (final data collection date for primary outcome measure)
A MR spectroscopy technique to measure creatine kinase flux in the heart is being developed [ Time Frame: three years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01110395 on ClinicalTrials.gov Archive Site
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Phosphorous Magnetic Resonance Spectroscopy of Heart
31P Magnetic Resonance Spectroscopy of Heart

Heart needs constant supply of energy to continue working. Phosphorous (31P) magnetic resonance spectroscopy allows a non-invasive tool to monitor heart energy metabolism. The purpose of this project is to develop an accurate and reproducible magnetic resonance spectroscopy technique to measure energy production in the heart.

The goal of this pilot project is to develop a phosphorous (31P) magnetic resonance spectroscopic (MRS) approach that will provide an accurate and reproducible measurement of creatine kinase (CK) flux in myocardium. The magnetic resonance pulse sequence will be developed on Siemens 3.0T human system. The accuracy of the techniques will be tested using the following two approaches

  1. Dobutamine infusion of 10 mcg/kg for approximately 35 minutes to increases the heart work. This will determine if the technique can accurately measure increased myocardial energy production due to increased work
  2. Test the technique in subjects with LV dysfunction due to prior anterior wall myocardial infarction. This patient group was chosen because results of studies in animal models have consistently shown a decrease in CK flux and in humans a decrease in PCr and ATP concentrations and CK activity.

Using these two subject groups we expect to test the sensitivity of the technique at increased and decreased myocardial energy production.
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Probability Sample

The study population will be healthy individuals and individuals with left ventricular dysfunction including men and women of all races.
  • Healthy Subjects
  • Left Ventricular Dysfunction
Drug: Dobutamine
Infusion of 10 mcg/kg for approximately 35 minutes
Other Name: dobutamine hydrochloride, injection
  • Healthy over 18 years
    Intervention: Drug: Dobutamine
  • LV dysfunction
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
June 2015
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy individuals and 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
Both
18 Years and older
Yes
Contact: Adil Bashir 314-362-7403
Contact: Kitty Krupp, RN 314-747-0183 kruppk@mir.wustl.edu
United States
 
NCT01110395
09-0533
Yes
Adil Bashir, Washington University School of Medicine
Washington University School of Medicine
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Principal Investigator: Adil Bashir, PhD Washington University School of Medicine
Washington University School of Medicine
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP