Recruiting

Ischemic Cardiomyopathy

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06814587

Conditions

Coronary Artery Disease

Coronary Artery Bypass Graft (CABG)

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Interventions

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)

Study Details

Brief 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 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.

Conditions

Coronary Artery Disease

Coronary Artery Bypass Graft (CABG)

Study ID

NCT06814587

Start date

Jul 1, 2024

Status verified date

Feb, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

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.

[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.

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.

Primary outcome measure

  • Assessment of Myocardial Metabolism and Viability via HP-13C MRI, FDG-PET, and SPECT MPI [ Time Frame: Baseline imaging at enrollment (pre-CABG) ]

Central Contacts and Locations

Central contacts

Sarah McNeil, RN

214-645-7700sarah.mcneil@utsouthwestern.edu

Cesia Rodriguez Gongora, RN

214/645-7739cesia.rodriguezgongora@utsouthwestern.edu

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Sarah McNeil

214-645-7700sarah.mcneil@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Coronary Artery Disease
  • Hyperpolarized 13C Pyruvate-MRI
  • FDG-PET
  • PET-MRI
  • SPECT-MPI
  • Myocardial Viability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-02-27.