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Magnetic Resonance Spectroscopy Studies of Cardiac Muscle Metabolism

This study is currently recruiting participants.
Verified April 2017 by Johns Hopkins University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00181259
First Posted: September 16, 2005
Last Update Posted: May 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
The metabolism of the heart provides the chemical energy needed to fuel ongoing normal heart contraction. Magnetic resonance spectroscopy is a technique used in a MRI scanner that can be used to measure and study heart metabolism directly but without blood sampling or obtaining tissue biopsies. One of the hypotheses this study aims to investigate is whether energy metabolism is reduced in heart failure and whether that contributes to the poor heart function.

Condition
Heart Failure, Congestive

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: In Vivo Cardiac Metabolism in Normal, Ischemic, and Cardiomyopathic Patients During Rest and Stress

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Phosphocreatine/adenosine triphosphate (PCr/ATP) and creatine kinase (CK) flux [ Time Frame: At time of magnetic resonance spectroscopy (MRS) ]
    Can non-invasive magnetic resonance imaging and spectroscopy techniques be developed, validated, and implemented on clinical MR scanners in order to address the questions of a.) the extent to which myocardial high-energy phosphate (HEP), creatine (Cr), or sodium concentrations change in response to and after transient ischemia or chronic ischemic injury, b.) the extent to which myocardial high-energy phosphates, creatine, or sodium concentrations as well as HEP flux are altered in cardiomyopathic patients with and without/ congestive heart failure, c.) can spatial differences in cardiac metabolites (HEP, Cr) or ions (Na) induced by ischemic injury be identified with novel, non-invasive imaging techniques?


Secondary Outcome Measures:
  • Phosphocreatine (PCr) [ Time Frame: At time of MRS ]
    Can non-invasive magnetic resonance imaging and spectroscopy techniques be developed, validated, and implemented on clinical MR scanners in order to address the questions of a.) the extent to which myocardial high-energy phosphate (HEP), creatine (Cr), or sodium concentrations change in response to and after transient ischemia or chronic ischemic injury, b.) the extent to which myocardial high-energy phosphates, creatine, or sodium concentrations as well as HEP flux are altered in cardiomyopathic patients with and without/ congestive heart failure, c.) can spatial differences in cardiac metabolites (HEP, Cr) or ions (Na) induced by ischemic injury be identified with novel, non-invasive imaging techniques?

  • ATP [ Time Frame: At time of MRS ]
    Can non-invasive magnetic resonance imaging and spectroscopy techniques be developed, validated, and implemented on clinical MR scanners in order to address the questions of a.) the extent to which myocardial high-energy phosphate (HEP), creatine (Cr), or sodium concentrations change in response to and after transient ischemia or chronic ischemic injury, b.) the extent to which myocardial high-energy phosphates, creatine, or sodium concentrations as well as HEP flux are altered in cardiomyopathic patients with and without/ congestive heart failure, c.) can spatial differences in cardiac metabolites (HEP, Cr) or ions (Na) induced by ischemic injury be identified with novel, non-invasive imaging techniques?

  • [Cr] or total creatine (CR), or CR/water ratio [ Time Frame: At time of MRS ]
    Can non-invasive magnetic resonance imaging and spectroscopy techniques be developed, validated, and implemented on clinical MR scanners in order to address the questions of a.) the extent to which myocardial high-energy phosphate (HEP), creatine (Cr), or sodium concentrations change in response to and after transient ischemia or chronic ischemic injury, b.) the extent to which myocardial high-energy phosphates, creatine, or sodium concentrations as well as HEP flux are altered in cardiomyopathic patients with and without/ congestive heart failure, c.) can spatial differences in cardiac metabolites (HEP, Cr) or ions (Na) induced by ischemic injury be identified with novel, non-invasive imaging techniques?

  • Sodium (NA) [ Time Frame: At time of MRS ]
    Can non-invasive magnetic resonance imaging and spectroscopy techniques be developed, validated, and implemented on clinical MR scanners in order to address the questions of a.) the extent to which myocardial high-energy phosphate (HEP), creatine (Cr), or sodium concentrations change in response to and after transient ischemia or chronic ischemic injury, b.) the extent to which myocardial high-energy phosphates, creatine, or sodium concentrations as well as HEP flux are altered in cardiomyopathic patients with and without/ congestive heart failure, c.) can spatial differences in cardiac metabolites (HEP, Cr) or ions (Na) induced by ischemic injury be identified with novel, non-invasive imaging techniques?

  • ATP flux [ Time Frame: At time of MRS ]
    Can non-invasive magnetic resonance imaging and spectroscopy techniques be developed, validated, and implemented on clinical MR scanners in order to address the questions of a.) the extent to which myocardial high-energy phosphate (HEP), creatine (Cr), or sodium concentrations change in response to and after transient ischemia or chronic ischemic injury, b.) the extent to which myocardial high-energy phosphates, creatine, or sodium concentrations as well as HEP flux are altered in cardiomyopathic patients with and without/ congestive heart failure, c.) can spatial differences in cardiac metabolites (HEP, Cr) or ions (Na) induced by ischemic injury be identified with novel, non-invasive imaging techniques?

  • 31P distribution or metabolite map [ Time Frame: At time of MRS ]
    Can non-invasive magnetic resonance imaging and spectroscopy techniques be developed, validated, and implemented on clinical MR scanners in order to address the questions of a.) the extent to which myocardial high-energy phosphate (HEP), creatine (Cr), or sodium concentrations change in response to and after transient ischemia or chronic ischemic injury, b.) the extent to which myocardial high-energy phosphates, creatine, or sodium concentrations as well as HEP flux are altered in cardiomyopathic patients with and without/ congestive heart failure, c.) can spatial differences in cardiac metabolites (HEP, Cr) or ions (Na) induced by ischemic injury be identified with novel, non-invasive imaging techniques?

  • 23Na distribution or metabolite map [ Time Frame: At time of MRS ]
    Can non-invasive magnetic resonance imaging and spectroscopy techniques be developed, validated, and implemented on clinical MR scanners in order to address the questions of a.) the extent to which myocardial high-energy phosphate (HEP), creatine (Cr), or sodium concentrations change in response to and after transient ischemia or chronic ischemic injury, b.) the extent to which myocardial high-energy phosphates, creatine, or sodium concentrations as well as HEP flux are altered in cardiomyopathic patients with and without/ congestive heart failure, c.) can spatial differences in cardiac metabolites (HEP, Cr) or ions (Na) induced by ischemic injury be identified with novel, non-invasive imaging techniques?

  • CR distribution or metabolite map [ Time Frame: At time of MRS ]
    Can non-invasive magnetic resonance imaging and spectroscopy techniques be developed, validated, and implemented on clinical MR scanners in order to address the questions of a.) the extent to which myocardial high-energy phosphate (HEP), creatine (Cr), or sodium concentrations change in response to and after transient ischemia or chronic ischemic injury, b.) the extent to which myocardial high-energy phosphates, creatine, or sodium concentrations as well as HEP flux are altered in cardiomyopathic patients with and without/ congestive heart failure, c.) can spatial differences in cardiac metabolites (HEP, Cr) or ions (Na) induced by ischemic injury be identified with novel, non-invasive imaging techniques?


Estimated Enrollment: 500
Study Start Date: January 1988
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Detailed Description:
This study uses magnetic resonance (MR) spectroscopy to study heart metabolism and function in normal subjects and patients with left ventricular hypertrophy, dilated cardiomyopathy, and those with coronary artery disease.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with coronary artery disease, dilated cardiomyopathy, or left ventricular hypertrophy
Criteria

Inclusion Criteria:

  • age > 18 years
  • Healthy subjects: no history of heart disease
  • Dilated cardiomyopathy: history of heart failure, ejection fraction (EF) <40%
  • Left ventricular hypertrophy: wall thickness >1.2cm
  • Coronary artery disease: >50% coronary lesion or positive stress test

Exclusion Criteria:

  • contraindication to MRI
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181259


Contacts
Contact: Robert G. Weiss, MD 410-955-1703 rweiss@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Medical Institutions Recruiting
Baltimore, Maryland, United States, 21205
Contact: Tricia Steinberg, RN, MSN    443-287-3469    asteinb3@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Robert G. Weiss, MD Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00181259     History of Changes
Other Study ID Numbers: NA_00044690
R01HL061912-14 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: May 2, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases