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
N/A
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
The trial investigates ischemic cardiomyopathy (ICM), a condition where blood flow to the heart muscle is reduced, affecting heart function. Researchers aim to validate a new combined imaging approach that examines heart muscle viability and metabolism using multiple advanced techniques. This method is designed to improve understanding of heart disease severity and response to surgical treatment in patients with ICM and to establish baseline data from healthy volunteers. The study uses three main imaging tests: Single Photon Emission Computed Tomography Myocardial Perfusion Imaging (SPECT MPI), 18F-fluorodeoxyglucose positron emission tomography (FDG-PET), and Hyperpolarized Carbon-13 Pyruvate Magnetic Resonance Imaging (HP-13C MRI). Healthy volunteers will have one imaging session to set baseline parameters. Patients with advanced ICM scheduled for coronary artery bypass graft (CABG) surgery will undergo imaging before surgery and again 3 to 6 months after surgery to monitor changes in heart metabolism and viability. Participants will be assessed through these imaging sessions, which will be performed on separate days within a three-month period. The study involves collecting detailed metabolic and viability data to correlate with clinical indicators of heart function. Researchers will evaluate these results to better understand heart muscle metabolism and recovery after surgery, with total participation lasting several months including follow-up imaging.
CONDITIONS
Brief 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...
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Age between 18 and 80 years
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Male or female participants
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For ICM patients: scheduled for coronary artery bypass graft (CABG) surgery
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Presence of one or more stenotic coronary artery vessels
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Left ventricular ejection fraction (LVEF) 40% or less, or clinical need for myocardial viability assessment
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Able to tolerate imaging protocols including fasting and glucose regulation
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Use of medication within 24 hours before scans is allowed
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Negative pregnancy test for females of childbearing age on scan day
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Eligible for 3T MRI, SPECT MPI, and FDG-PET
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For healthy volunteers: no history of coronary artery disease or diabetes
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Negative pregnancy test for females of childbearing age on scan day
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Eligible for 3T MRI, SPECT MPI, and FDG-PET
You will not qualify if you...
- Age under 18 or over 80 years
- Not scheduled for CABG or no confirmed coronary artery disease (for ICM group)
- Prior myocardial infarction with transmural scar greater than 50%
- Contraindications to 3T MRI (e.g., pacemakers, metal implants), SPECT MPI (e.g., significant arrhythmias), or FDG-PET (e.g., severe glucose metabolism impairment)
- Positive pregnancy test or currently breastfeeding females on scan day
- Severe kidney impairment (GFR less than 30 mL/min) or contraindication to FDG PET tracer
- Uncontrolled diabetes mellitus (HbA1c greater than 9%) or inability to maintain stable glucose for FDG PET
- History of coronary artery disease or diabetes (for healthy volunteer group)
- Other medical conditions deemed exclusionary by the study team
- Claustrophobia or other conditions preventing MRI or imaging procedures
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants undergo separate imaging sessions on different days to assess myocardial metabolism and viability using HP-13C MRI, FDG-PET, and SPECT MPI.
3 imaging visits on separate days
Duration - 3 to 6 months after surgery
Participants with ischemic cardiomyopathy are followed up 3 to 6 months after coronary artery bypass graft (CABG) surgery to evaluate changes in myocardial metabolism and function using repeat HP-13C MRI and FDG-PET imaging.
1 follow-up imaging visit
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
C
Cesia Rodriguez Gongora, RN
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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