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

February 24, 2026 updated by: Gaurav Sharma, University of Texas Southwestern Medical Center
This prospective, non-blinded, single-center, translational research study aims to validate a multimodal advanced imaging exam for cardiac viability. The protocol utilizes three distinct imaging modalities: Single Photon Emission Computed Tomography Myocardial Perfusion Imaging (SPECT MPI), 18F-fluorodeoxyglucose positron emission tomography (FDG-PET), and Hyperpolarized Carbon-13 (HP-13C) Pyruvate Magnetic Resonance Imaging (MRI). Under this protocol, the SPECT MPI and FDG-PET exams will be used in combination to comprehensively assess myocardial viability. Concurrently, the HP-13C Pyruvate MRI will be utilized to provide additional insights into myocardial metabolism. The study will evaluate healthy volunteers to establish baseline parameters and patients with ischemic cardiomyopathy (ICM) before and after surgical revascularization.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

schemic cardiomyopathy (ICM), characterized by compromised blood flow to the heart muscle, demands innovative solutions to accurately assess myocardial viability and metabolic function. While myocardial viability assessment is a widely practiced concept for selecting patients for revascularization, current imaging techniques often require separate sessions and lack holistic functional data.

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This project introduces a novel hybrid multimodal imaging method designed to holistically understand the interplay between metabolism and perfusion in ischemic cardiomyopathy. To achieve this, the study deliberately partitions imaging objectives:

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Myocardial Viability: SPECT MPI and 18F-FDG PET will be used together to assess myocardial viability. FDG-PET exploits the preferential uptake of glucose by metabolically active cells to identify viable myocardial tissue within ischemic regions.

Myocardial Metabolism: HP-13C-MRI provides additional, distinct insights into myocardial metabolism. By tracking the conversion of hyperpolarized 13C-pyruvate into metabolic intermediates like bicarbonate and lactate, this technique allows for the real-time quantification of alterations in cardiac substrate utilization and oxidative metabolism.

The study will enroll a total of 15 human subjects divided into two primary groups:

Healthy Participants (n=6): Individuals with normal left ventricular ejection fraction (LVEF > 0.50) to establish baseline imaging parameters.

ICM Participants (n=9): Patients with advanced ischemic cardiomyopathy and low LVEF (≤ 40%) scheduled for standard-of-care CABG surgery.

Due to current technical constraints regarding multi-nuclear support on hybrid PET-MRI scanners, the imaging modalities will be acquired on separate days within a 3-month period. The ICM cohort will be evaluated at two critical time points: preoperatively before CABG surgery, and longitudinally at one follow-up point 3-6 months post-surgery. Ultimately, this multimodal approach seeks to provide a non-invasive, highly accurate evaluation of disease severity, progression, and postoperative myocardial response to surgical revascularization.

Study Objectives

Primary Objective:

To evaluate myocardial metabolism, viability, and mechanical function in preoperative ICM patients with low LVEF (≤ 40%) scheduled for Coronary Artery Bypass Graft (CABG) using a combined assessment of HP-13C-MRI, FDG-PET, and SPECT MPI. This aims to correlate metabolic and viability data with clinical indicators, providing insights into abnormal cardiac metabolism.

Secondary Objectives:

Secondary Objective 1: To establish baseline metabolic, viability, and mechanical function parameters in healthy subjects with normal LVEF (> 0.50) using the combined HP-13C-MRI, FDG-PET, and SPECT MPI approach, serving as a comparative foundation.

Secondary Objective 2: To longitudinally assess changes in myocardial metabolism, viability, and mechanical function in the ICM patient cohort at 3-6 months post-surgical revascularization (CABG). This aims to elucidate the impact of surgical revascularization on postoperative myocardial changes.

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study includes patients with ischemic cardiomyopathy undergoing CABG and healthy controls to establish metabolic reference values.

Description

Study Population Description The study population will consist of 12 to 15 human subjects divided into two main groups. The first group includes 6 healthy individuals with a normal left ventricular ejection fraction (LVEF > 0.50). The second group comprises 9 patients with advanced ischemic cardiomyopathy (ICM) and a low LVEF (< 0.40) who are scheduled for standard-of-care Coronary Artery Bypass Graft (CABG) surgery. The study team will aim to recruit a mixed-sex, age-matched population with equal numbers for all metabolic imaging studies.

Ischemic Cardiomyopathy (ICM) Patient Cohort

Inclusion Criteria:

Male or Female, age 18-80 years. Patient scheduled for Coronary Artery Bypass Surgery as standard of care therapy per clinical guidelines.

Presence of 1 or more stenotic coronary artery vessels. Left Ventricular Ejection Fraction (LVEF) ≤ 40%, or clinical indication for myocardial viability assessment.

Able to tolerate FDG PET/MRI protocol and preparation (e.g., fasting state, glucose regulation).

Medication use within 24 hours of the scan is allowed and will be reported. Negative pregnancy test for females of childbearing age (on the day of scanning).

No known contraindications to 3T MRI, SPECT MPI, or FDG PET.

Exclusion Criteria:

Male or female, age < 18 or > 80 years of age. Patients not scheduled for CABG or those without confirmed coronary artery disease (CAD).

History of prior myocardial infarction with transmural scar > 50% (based on prior imaging or clinical history).

Patient not eligible for 3T MRI (Any condition or device precluding safe MRI e.g., pacemakers, defibrillators, metal implants), SPECT (significant arrhythmias or hemodynamic instability), or FDG-PET (e.g., severely impaired glucose metabolism).

Positive pregnancy test or females currently breastfeeding (on the day of scanning).

Severe renal impairment (GFR < 30 mL/min) or contraindication to FDG PET tracer.

History of uncontrolled diabetes mellitus (HbA1c > 9%) or inability to achieve stable glucose levels for FDG PET preparation.

Healthy Volunteer Cohort

Inclusion Criteria:

Male or Female, age 18-80 years. No history of coronary artery disease or diabetes. Eligible for 3T MRI, SPECT, and FDG-PET. Negative pregnancy test for females of childbearing age (on the day of scanning).

Exclusion Criteria:

History of coronary artery disease, diabetes, or other medical conditions deemed exclusionary by the study team.

Positive pregnancy test or females currently breastfeeding (on the day of scanning).

Contraindications to MRI (e.g., metallic implants, claustrophobia), SPECT MPI, or FDG-PET.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Control Group (H)
1.1. Group Description This cohort consists of healthy individuals (n=6) with normal left ventricular ejection fraction (LVEF >50%), no history of coronary artery disease, and no metabolic disorders. Participants will undergo a single session of hyperpolarized 13C pyruvate MRI (HP-13C MRI) and 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) to establish baseline myocardial metabolic and viability parameters.
Diagnostic test: Hyperpolarized 13C Pyruvate Magnetic Resonance Imaging (HP-13C MRI)
HP-13C MRI is a metabolic imaging technique that enables real-time assessment of myocardial substrate utilization by tracking the conversion of hyperpolarized [1-13C] pyruvate to metabolic intermediates such as bicarbonate and lactate. This imaging modality provides insights into oxidative metabolism and mitochondrial function, facilitating the identification of metabolically active and ischemic myocardial regions in patients with ischemic cardiomyopathy.
Other Names:
  • HP 13C-MRI, Hyperpolarized Carbon-13 Pyruvate MRI
Diagnostic test: [¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)
FDG-PET is a molecular imaging technique used to assess myocardial viability by quantifying glucose uptake in cardiac tissue. This method differentiates viable myocardium, which retains metabolic activity, from non-viable scar tissue. FDG-PET is widely used in ischemic cardiomyopathy for viability assessment to guide revascularization decisions.
Other Names:
  • FDG PET, 18F-FDG PET, Fluorodeoxyglucose PET
Diagnostic test: SPECT MPI (Single Photon Emission Computed Tomography Myocardial Perfusion Imaging)
This procedure involves a Rest and a Stress SPECT Myocardial Perfusion Imaging Study. It uses myocardial perfusion imaging (MPI) with a radioactive tracer to compare pictures of the heart at rest and during stress, induced either by treadmill exercise or the medication Regadenoson.
Pre-CABG Ischemic Cardiomyopathy (Pre-CABG ICM)
2.1. Group Description This cohort includes patients with ischemic cardiomyopathy (n=6) scheduled for coronary artery bypass grafting (CABG) with LVEF <35%. Participants will undergo preoperative HP-13C MRI and FDG-PET to assess myocardial metabolism and viability prior to revascularization.
Diagnostic test: Hyperpolarized 13C Pyruvate Magnetic Resonance Imaging (HP-13C MRI)
HP-13C MRI is a metabolic imaging technique that enables real-time assessment of myocardial substrate utilization by tracking the conversion of hyperpolarized [1-13C] pyruvate to metabolic intermediates such as bicarbonate and lactate. This imaging modality provides insights into oxidative metabolism and mitochondrial function, facilitating the identification of metabolically active and ischemic myocardial regions in patients with ischemic cardiomyopathy.
Other Names:
  • HP 13C-MRI, Hyperpolarized Carbon-13 Pyruvate MRI
Diagnostic test: [¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)
FDG-PET is a molecular imaging technique used to assess myocardial viability by quantifying glucose uptake in cardiac tissue. This method differentiates viable myocardium, which retains metabolic activity, from non-viable scar tissue. FDG-PET is widely used in ischemic cardiomyopathy for viability assessment to guide revascularization decisions.
Other Names:
  • FDG PET, 18F-FDG PET, Fluorodeoxyglucose PET
Diagnostic test: SPECT MPI (Single Photon Emission Computed Tomography Myocardial Perfusion Imaging)
This procedure involves a Rest and a Stress SPECT Myocardial Perfusion Imaging Study. It uses myocardial perfusion imaging (MPI) with a radioactive tracer to compare pictures of the heart at rest and during stress, induced either by treadmill exercise or the medication Regadenoson.
Post-CABG Follow-up (Post-CABG ICM)
3.1. Group Description This cohort consists of patients post-CABG (n=12), imaged at two follow-up time points: 4-6 months (n=6) and 10-12 months (n=6) after surgery. Participants will undergo repeat HP-13C MRI and FDG-PET to evaluate longitudinal metabolic changes and myocardial functional recovery following revascularization.
Diagnostic test: Hyperpolarized 13C Pyruvate Magnetic Resonance Imaging (HP-13C MRI)
HP-13C MRI is a metabolic imaging technique that enables real-time assessment of myocardial substrate utilization by tracking the conversion of hyperpolarized [1-13C] pyruvate to metabolic intermediates such as bicarbonate and lactate. This imaging modality provides insights into oxidative metabolism and mitochondrial function, facilitating the identification of metabolically active and ischemic myocardial regions in patients with ischemic cardiomyopathy.
Other Names:
  • HP 13C-MRI, Hyperpolarized Carbon-13 Pyruvate MRI
Diagnostic test: [¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)
FDG-PET is a molecular imaging technique used to assess myocardial viability by quantifying glucose uptake in cardiac tissue. This method differentiates viable myocardium, which retains metabolic activity, from non-viable scar tissue. FDG-PET is widely used in ischemic cardiomyopathy for viability assessment to guide revascularization decisions.
Other Names:
  • FDG PET, 18F-FDG PET, Fluorodeoxyglucose PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Myocardial Metabolism and Viability via HP-13C MRI, FDG-PET, and SPECT MPI
Time Frame: Baseline imaging at enrollment (pre-CABG)
This outcome evaluates the ability of hyperpolarized 13C pyruvate MRI (HP-13C MRI) to assess myocardial metabolism, alongside myocardial viability assessment using FDG-PET and SPECT MPI, in patients with ischemic cardiomyopathy compared with healthy subjects. Quantitative assessment with HP-13C MRI will focus on the metabolic conversion of pyruvate to intermediates like bicarbonate and lactate as a marker of oxidative versus anaerobic metabolism. These results will be compared with regional FDG uptake measured by FDG-PET and perfusion findings from SPECT MPI. The performance of these metabolic biomarkers will be evaluated and compared with established viability imaging techniques to determine their relative accuracy in characterizing ischemic cardiomyopathy.
Baseline imaging at enrollment (pre-CABG)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Myocardial Metabolic Profiles and Viability in Ischemic Cardiomyopathy Patients vs. Healthy Subjects
Time Frame: Baseline imaging at enrollment across separate imaging visits (SPECT MPI, FDG-PET, and HP-13C MRI on different days).
This outcome evaluates differences in myocardial metabolic parameters and viability markers between healthy controls and preoperative ischemic cardiomyopathy patients. The goal is to establish metabolic reference values in healthy myocardium and determine metabolic alterations in ischemic regions.
Baseline imaging at enrollment across separate imaging visits (SPECT MPI, FDG-PET, and HP-13C MRI on different days).
Longitudinal Changes in Myocardial Metabolism Post-CABG
Time Frame: Follow-up imaging at a single time point 3-6 months post-CABG.
This outcome assesses metabolic and functional changes in myocardial segments post-revascularization by evaluating HP-13C MRI and FDG-PET parameters post-CABG. Improvement or changes in myocardial metabolism, viability, and glucose uptake will be correlated with mechanical function recovery.
Follow-up imaging at a single time point 3-6 months post-CABG.
Correlation of Preoperative Multimodal Imaging with Post-Surgical Exam
Time Frame: Measured at baseline (pre-CABG) and at the 3-6 months post-CABG follow-up.
This outcome investigates whether preoperative multimodal imaging findings predict post-surgical changes in myocardial function, such as left ventricular ejection fraction (LVEF) and regional wall motion
Measured at baseline (pre-CABG) and at the 3-6 months post-CABG follow-up.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility, Safety, and Reproducibility of the Multimodal Advanced Imaging Exam
Time Frame: Assessed at each imaging session (baseline imaging and follow-up imaging at 3-6 months post-CABG).
This outcome assesses the technical feasibility, safety, and image quality of conducting HP-13C MRI, FDG-PET, and SPECT MPI. While the long-term goal is a single combined exam, this study evaluates the feasibility of these acquisitions performed on separate days to establish their combined value. Factors evaluated include adverse events, physiologic monitoring (heart rate, blood pressure, ECG), and successful metabolic quantification.
Assessed at each imaging session (baseline imaging and follow-up imaging at 3-6 months post-CABG).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

American Heart Association

Investigators

  • Principal Investigator: Gaurav Sharma, PhD, MBA, University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

January 30, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

February 7, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2024-0809

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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