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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-80
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Hyperpolarized 13C Pyruvate Magnetic Resonance Imaging (HP-13C MRI)

    Diagnostic test

    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.

  • [¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)

    Diagnostic test

    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.

  • SPECT MPI (Single Photon Emission Computed Tomography Myocardial Perfusion Imaging)

    Diagnostic test

    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.

Treatment groups

15 Participants
are divided into 3 treatment groups
Group A: Healthy Control Group (H)3 interventions
Group B: Pre-CABG Ischemic Cardiomyopathy (Pre-CABG ICM)3 interventions
Group C: Post-CABG Follow-up (Post-CABG ICM)2 interventions

Trial outcomes

Primary outcomes

1

Assessment of Myocardial Metabolism and Viability via HP-13C MRI, FDG-PET, and SPECT MPI

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.

Time frame
Baseline imaging at enrollment (pre-CABG)

Secondary outcomes

1

Comparison of Myocardial Metabolic Profiles and Viability in Ischemic Cardiomyopathy Patients vs. Healthy Subjects

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.

Time frame
Baseline imaging at enrollment across separate imaging visits (SPECT MPI, FDG-PET, and HP-13C MRI on different days).
2

Longitudinal Changes in Myocardial Metabolism 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.

Time frame
Follow-up imaging at a single time point 3-6 months post-CABG.
3

Correlation of Preoperative Multimodal Imaging with Post-Surgical Exam

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

Time frame
Measured at baseline (pre-CABG) and at the 3-6 months post-CABG follow-up.

Other outcomes

1

Feasibility, Safety, and Reproducibility of the Multimodal Advanced Imaging Exam

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.

Time frame
Assessed at each imaging session (baseline imaging and follow-up imaging at 3-6 months post-CABG).

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