Magnetic Resonance Spectroscopy Studies of Cardiac Muscle Metabolism

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Johns Hopkins University
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert G. Weiss, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00181259
First received: September 13, 2005
Last updated: November 11, 2015
Last verified: November 2015
  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: Time Perspective: Prospective
Official Title: In Vivo Cardiac Metabolism in Normal, Ischemic, and Cardiomyopathic Patients During Rest and Stress

Resource links provided by NLM:


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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2016
Estimated Primary Completion Date: January 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Robert G. Weiss, Professor of Medicine and Radiology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00181259     History of Changes
Other Study ID Numbers: NA_00044690  R01HL061912-14 
Study First Received: September 13, 2005
Last Updated: November 11, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on February 04, 2016