Combining advanced MRI and PET imaging for heart disease prognosis
Hyperpolarized 13C Pyruvate-MRI and FDG-PET in a Single Exam for the Prognosis of Ischemic Cardiomyopathy
This study is testing a new way of using advanced MRI and PET scans together to see if it can give better information about heart health for people with heart disease and those who are healthy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06814587 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a novel imaging approach that merges hyperpolarized 13C pyruvate magnetic resonance imaging (HP-13C-MRI) with fluorodeoxyglucose positron emission tomography (FDG-PET) in a single examination. The study aims to improve the prognostic assessment of ischemic cardiomyopathy by determining if this combined imaging technique offers better insights into myocardial viability and metabolic function compared to traditional methods. Participants include patients scheduled for coronary artery bypass grafting (CABG) and healthy controls, with assessments focusing on metabolic profiles and clinical outcomes. The study seeks to address the limitations of existing imaging modalities that often require multiple sessions and can yield discordant results.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20-80 with ischemic cardiomyopathy scheduled for CABG and a left ventricular ejection fraction of 40% or less.
Not a fit: Patients with prior extensive myocardial infarction, severe renal impairment, or contraindications to MRI or PET will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate prognostic assessments and better treatment strategies for patients with ischemic cardiomyopathy.
How similar studies have performed: While the combination of these imaging modalities is innovative, similar studies have shown promise in improving diagnostic accuracy in cardiac conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Study Population Description The study population will consist of 12 to 15 human subjects divided into two main groups. The first group includes 6 healthy individuals with a normal left ventricular ejection fraction (LVEF \> 0.50). The second group comprises 9 patients with advanced ischemic cardiomyopathy (ICM) and a low LVEF (\< 0.40) who are scheduled for standard-of-care Coronary Artery Bypass Graft (CABG) surgery. The study team will aim to recruit a mixed-sex, age-matched population with equal numbers for all metabolic imaging studies. Ischemic Cardiomyopathy (ICM) Patient Cohort Inclusion Criteria: 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. Exclusion Criteria: 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 this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Gaurav Sharma, PhD, MBA — University of Texas Southwestern Medical Center
- Study coordinator: Sarah McNeil, RN
- Email: sarah.mcneil@utsouthwestern.edu
- Phone: 214-645-7700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.