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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

Design: This is a prospective, non-blinded, single-center study utilizing a hybrid PET-MR scanner for simultaneous imaging. Participants will be divided into three groups: Healthy subjects (n=6) with normal LVEF for baseline reference. Preoperative patients (n=6) with low LVEF due to ischemic cardiomyopathy undergoing coronary artery bypass grafting (CABG). Post-CABG patients (n=6 at 4-6 months, n=6 at 10-12 months) to evaluate post-surgical changes. Procedures: Undergo HP-13C-MRI and FDG-PET imaging in a single session. Blood samples for metabolic biomarkers (lactate, pyruvate, triglycerides, insulin, glucose). Standard clinical cardiac imaging (Echocardiography, SPECT Myocardial Perfusion Imaging).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: t
View:

⁃ Participants must meet all of the following criteria:

• Age between 20-80 years

• Eligible for MRI, PET, and contrast agents (based on institutional screening protocols)

• Scheduled for CABG (for ischemic cardiomyopathy patients)

• Left ventricular ejection fraction (LVEF) ≤ 40% or clinical indication for myocardial viability assessment

• No history of coronary artery disease or diabetes (for healthy controls)

• Negative pregnancy test (for female participants of childbearing potential)

Locations
United States
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Sarah McNeil, RN
sarah.mcneil@utsouthwestern.edu
214-645-7700
Backup
Cesia Rodriguez Gongora, RN
cesia.rodriguezgongora@utsouthwestern.edu
214/645-7739
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 12
Treatments
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.
Sponsors
Collaborators: American Heart Association
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov