Hyperpolarized 13C Pyruvate-MRI and FDG-PET in a Single Exam for the Prognosis of Ischemic Cardiomyopathy

Description

The goal of this clinical trial is to evaluate a novel imaging approach that combines hyperpolarized 13C pyruvate magnetic resonance imaging (HP-13C-MRI) and \[¹⁸F\]Fluorodeoxyglucose positron emission tomography (FDG-PET) in a single exam to improve the prognostic assessment of ischemic cardiomyopathy. The main questions this study aims to answer are: Primary Hypothesis: Can the simultaneous acquisition of HP-13C-MRI and FDG-PET data improve the metabolic, viability, and mechanical function assessment in ischemic cardiomyopathy? Primary Outcome Measure: To determine whether the combined HP-13C-MRI/FDG-PET approach provides better prognostic value for ischemic cardiomyopathy compared to current separate imaging modalities. Secondary Outcome Measures: Baseline metabolic and viability profiles in healthy individuals. Correlation of metabolic imaging with clinical outcomes in preoperative patients with low left ventricular ejection fraction (LVEF). Longitudinal changes in myocardial metabolism post-surgery. Study Design: This is a prospective, non-blinded, single-center study utilizing a hybrid PET-MR scanner for simultaneous imaging. Participants will be divided into three groups: Healthy subjects (n=6) with normal LVEF for baseline reference. Preoperative patients (n=6) with low LVEF due to ischemic cardiomyopathy undergoing coronary artery bypass grafting (CABG). Post-CABG patients (n=6 at 4-6 months, n=6 at 10-12 months) to evaluate post-surgical changes. Procedures: Undergo HP-13C-MRI and FDG-PET imaging in a single session. Blood samples for metabolic biomarkers (lactate, pyruvate, triglycerides, insulin, glucose). Standard clinical cardiac imaging (Echocardiography, SPECT Myocardial Perfusion Imaging).

Conditions

Coronary Artery Disease, Coronary Artery Bypass Graft (CABG)

Study Overview

Study Details

Study overview

The goal of this clinical trial is to evaluate a novel imaging approach that combines hyperpolarized 13C pyruvate magnetic resonance imaging (HP-13C-MRI) and \[¹⁸F\]Fluorodeoxyglucose positron emission tomography (FDG-PET) in a single exam to improve the prognostic assessment of ischemic cardiomyopathy. The main questions this study aims to answer are: Primary Hypothesis: Can the simultaneous acquisition of HP-13C-MRI and FDG-PET data improve the metabolic, viability, and mechanical function assessment in ischemic cardiomyopathy? Primary Outcome Measure: To determine whether the combined HP-13C-MRI/FDG-PET approach provides better prognostic value for ischemic cardiomyopathy compared to current separate imaging modalities. Secondary Outcome Measures: Baseline metabolic and viability profiles in healthy individuals. Correlation of metabolic imaging with clinical outcomes in preoperative patients with low left ventricular ejection fraction (LVEF). Longitudinal changes in myocardial metabolism post-surgery. Study Design: This is a prospective, non-blinded, single-center study utilizing a hybrid PET-MR scanner for simultaneous imaging. Participants will be divided into three groups: Healthy subjects (n=6) with normal LVEF for baseline reference. Preoperative patients (n=6) with low LVEF due to ischemic cardiomyopathy undergoing coronary artery bypass grafting (CABG). Post-CABG patients (n=6 at 4-6 months, n=6 at 10-12 months) to evaluate post-surgical changes. Procedures: Undergo HP-13C-MRI and FDG-PET imaging in a single session. Blood samples for metabolic biomarkers (lactate, pyruvate, triglycerides, insulin, glucose). Standard clinical cardiac imaging (Echocardiography, SPECT Myocardial Perfusion Imaging).

Hyperpolarized 13C Pyruvate-MRI and FDG-PET in a Single Exam for the Prognosis of Ischemic Cardiomyopathy

Hyperpolarized 13C Pyruvate-MRI and FDG-PET in a Single Exam for the Prognosis of Ischemic Cardiomyopathy

Condition
Coronary Artery Disease
Intervention / Treatment

-

Contacts and Locations

Dallas

University of Texas Southwestern Medical Center, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age between 20-80 years
  • * Eligible for MRI, PET, and contrast agents (based on institutional screening protocols)
  • * Scheduled for CABG (for ischemic cardiomyopathy patients)
  • * Left ventricular ejection fraction (LVEF) ≤ 40% or clinical indication for myocardial viability assessment
  • * No history of coronary artery disease or diabetes (for healthy controls)
  • * Negative pregnancy test (for female participants of childbearing potential)
  • * Age \<20 or \>80 years
  • * Prior extensive myocardial infarction (defined as \>50% transmural scar on viability imaging)
  • * Contraindications to MRI, PET, or contrast agents (including severe claustrophobia or allergy)
  • * Pregnant or breastfeeding women
  • * Severe renal impairment (GFR \<30 mL/min/1.73m²)
  • * Uncontrolled diabetes (HbA1c \>9%)

Ages Eligible for Study

20 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Texas Southwestern Medical Center,

Gaurav Sharma, PhD, MBA, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

2026-06-30