Coronary Artery DiseaseFDG PET-HP MRINCT06814587
Hyperpolarized 13C Pyruvate-MRI and FDG-PET in a Single Exam for the Prognosis of Ischemic Cardiomyopathy
An observational study of Coronary Artery Disease and Coronary Artery Bypass Graft (CABG), run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Bypass Graft (CABG)
- What is being tested?
- Hyperpolarized 13C Pyruvate Magnetic Resonance Imaging (HP-13C MRI), [¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) and SPECT MPI (Single Photon Emission Computed Tomography Myocardial Perfusion Imaging)
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 30 Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study includes patients with ischemic cardiomyopathy undergoing CABG and healthy controls to establish metabolic reference values.
Who may be able to join
- 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.
- 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).
Who cannot join
- 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.
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- Healthy Volunteer Cohort
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Sarah McNeil, 214-645-7700, sarah.mcneil@utsouthwestern.edu
About this study
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.
Read the 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.
- Being tested
- Hyperpolarized 13C Pyruvate Magnetic Resonance Imaging (HP-13C MRI), [¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET), SPECT MPI (Single Photon Emission Computed Tomography Myocardial Perfusion Imaging)
- Keywords
- Coronary Artery Disease, Hyperpolarized 13C Pyruvate-MRI, FDG-PET, PET-MRI, SPECT-MPI, Myocardial Viability
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 13C Pyruvate Magnetic Resonance Imaging (HP-13C MRI)Diagnostic test
Also called HP 13C-MRI, Hyperpolarized Carbon-13 Pyruvate 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.
[¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)Diagnostic test
Also called FDG PET, 18F-FDG PET, Fluorodeoxyglucose 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Hyperpolarized 13C Pyruvate Magnetic Resonance Imaging (HP-13C MRI); Diagnostic Test: [¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET); Diagnostic Test: SPECT MPI (Single Photon Emission Computed Tomography Myocardial Perfusion Imaging) | |
| 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. Receives: Diagnostic Test: Hyperpolarized 13C Pyruvate Magnetic Resonance Imaging (HP-13C MRI); Diagnostic Test: [¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET); Diagnostic Test: SPECT MPI (Single Photon Emission Computed Tomography Myocardial Perfusion Imaging) | |
| 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. Receives: Diagnostic Test: Hyperpolarized 13C Pyruvate Magnetic Resonance Imaging (HP-13C MRI); Diagnostic Test: [¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline imaging at enrollment (pre-CABG)
Secondary outcomes (3)
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.
Measured: 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
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.
Measured: Follow-up imaging at a single time point 3-6 months post-CABG.
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
Measured: Measured at baseline (pre-CABG) and at the 3-6 months post-CABG follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Jul 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Gaurav Sharma, University of Texas Southwestern Medical Center
- Investigators
- Gaurav Sharma, PhD, MBA, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814587
- Sponsor's protocol ID
- STU-2024-0809
- Acronym
- FDG PET-HP MRI
- Status last verified
- Sep 2026
- First submitted
- 30 Jan 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No