Actively Recruiting
Hyperpolarized 13C Pyruvate-MRI and FDG-PET in a Single Exam for the Prognosis of Ischemic Cardiomyopathy
Led by University of Texas Southwestern Medical Center · Updated on 2026-02-27
15
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
A
American Heart Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Hyperpolarized 13C Pyruvate-MRI and FDG-PET in a Single Exam for the Prognosis of Ischemic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 80 years
- For ischemic cardiomyopathy patients: scheduled for coronary artery bypass surgery
- Presence of one or more narrowed coronary arteries
- Left ventricular ejection fraction (LVEF) of 40% or less, or clinical need for myocardial viability assessment
- Able to tolerate FDG PET/MRI preparation including fasting and glucose regulation
- Medication use within 24 hours before scan is allowed and will be reported
- Negative pregnancy test for females of childbearing potential on scan day
- Eligible for 3T MRI, SPECT MPI, and FDG-PET
- For healthy volunteers: normal LVEF above 50%
- No history of coronary artery disease or diabetes
- Negative pregnancy test for females of childbearing potential on scan day
You will not qualify if you...
- Age under 18 or over 80 years
- Not scheduled for CABG or no confirmed coronary artery disease
- Prior myocardial infarction with more than 50% transmural scar
- Ineligibility for 3T MRI (e.g., pacemakers, defibrillators, metal implants), SPECT (e.g., significant arrhythmias, hemodynamic instability), or FDG-PET (e.g., severely impaired glucose metabolism)
- Positive pregnancy test or currently breastfeeding on scan day
- Severe kidney impairment (glomerular filtration rate below 30 mL/min) or contraindication to FDG PET tracer
- Uncontrolled diabetes (HbA1c over 9%) or inability to maintain stable glucose levels for FDG PET preparation
- For healthy volunteers: history of coronary artery disease, diabetes, or other exclusionary medical conditions
- Contraindications to MRI, SPECT MPI, or FDG-PET such as metallic implants or claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
S
Sarah McNeil, RN
CONTACT
C
Cesia Rodriguez Gongora, RN
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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