RECRUITINGOBSERVATIONAL

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

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.

Who May Be Eligible (Plain English)

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 Who May Qualify: 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. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

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.

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.

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States