RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to evaluate a novel imaging approach that combines hyperpolarized 13C pyruvate magnetic resonance imaging (HP-13C-MRI) and \[¹⁸F\]Fluorodeoxyglucose positron emission tomography (FDG-PET) in a single exam to improve the prognostic assessment of ischemic cardiomyopathy. The main questions this study aims to answer are: Primary Hypothesis: Can the simultaneous acquisition of HP-13C-MRI and FDG-PET data improve the metabolic, viability, and mechanical function assessment in ischemic cardiomyopathy? Primary Outcome Measure: To determine whether the combined HP-13C-MRI/FDG-PET approach provides better prognostic value for ischemic cardiomyopathy compared to current separate imaging modalities. Secondary Outcome Measures: Baseline metabolic and viability profiles in healthy individuals. Correlation of metabolic imaging with clinical outcomes in preoperative patients with low left ventricular ejection fraction (LVEF). Longitudinal changes in myocardial metabolism post-surgery. Study 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).

Official Title

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

Quick Facts

Study Start:2024-07-01
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06814587

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age between 20-80 years
  2. * Eligible for MRI, PET, and contrast agents (based on institutional screening protocols)
  3. * Scheduled for CABG (for ischemic cardiomyopathy patients)
  4. * Left ventricular ejection fraction (LVEF) ≤ 40% or clinical indication for myocardial viability assessment
  5. * No history of coronary artery disease or diabetes (for healthy controls)
  6. * Negative pregnancy test (for female participants of childbearing potential)
  1. * Age \<20 or \>80 years
  2. * Prior extensive myocardial infarction (defined as \>50% transmural scar on viability imaging)
  3. * Contraindications to MRI, PET, or contrast agents (including severe claustrophobia or allergy)
  4. * Pregnant or breastfeeding women
  5. * Severe renal impairment (GFR \<30 mL/min/1.73m²)
  6. * Uncontrolled diabetes (HbA1c \>9%)

Contacts and Locations

Study Contact

Sarah McNeil, RN
CONTACT
214-645-7700
sarah.mcneil@utsouthwestern.edu
Cesia Rodriguez Gongora, RN
CONTACT
214/645-7739
cesia.rodriguezgongora@utsouthwestern.edu

Principal Investigator

Gaurav Sharma, PhD, MBA
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Gaurav Sharma, PhD, MBA, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Coronary Artery Disease
  • Hyperpolarized 13C Pyruvate-MRI
  • FDG-PET
  • PET-MRI
  • Myocardial Viability

Additional Relevant MeSH Terms

  • Coronary Artery Disease
  • Coronary Artery Bypass Graft (CABG)