Magnetic Resonance Spectroscopy Studies of Cardiac Muscle Metabolism

Heart Failure, Congestive Clinical Trial

Official title:

In Vivo Cardiac Metabolism in Normal, Ischemic, and Cardiomyopathic Patients During Rest and Stress

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00181259
• Other study ID #: NA_00044690
• Secondary ID: R01HL061912-14
• Status: Recruiting
• Start date: January 1988
• Est. completion date: August 2028

Study information

• Verified date: August 2023
• Source: Johns Hopkins University
• Contact: Robert G. Weiss, MD
• Phone: 410-955-1703
• Email: rweiss[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 2028
• Est. primary completion date: August 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Institutions	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phosphocreatine/adenosine triphosphate (PCr/ATP) and creatine kinase (CK) flux	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?	At time of magnetic resonance spectroscopy (MRS)
Secondary	Phosphocreatine (PCr)	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?	At time of MRS
Secondary	ATP	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?	At time of MRS
Secondary	[Cr] or total creatine (CR), or CR/water ratio	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?	At time of MRS
Secondary	Sodium (NA)	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?	At time of MRS
Secondary	ATP flux	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?	At time of MRS
Secondary	31P distribution or metabolite map	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?	At time of MRS
Secondary	23Na distribution or metabolite map	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?	At time of MRS
Secondary	CR distribution or metabolite map	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?	At time of MRS