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

Recruiting now

Conditions studied: Coronary Artery Disease, Coronary Artery Bypass Graft (CABG)

In brief

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.

Key facts

Study ID

NCT06814587

Run by

University of Texas Southwestern Medical Center

People needed

15

Starts

2024-07-01

Expected to finish

2026-06-30

Last updated by the study team

2026-02-27

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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