NCT06814587 Hyperpolarized 13C Pyruvate-MRI and FDG-PET in a Single Exam for the Prognosis of Ischemic Cardiomyopathy
| NCT ID | NCT06814587 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2024-07-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Gaurav Sharma, PhD, MBA
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT06814587 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06814587 currently recruiting?
Yes, NCT06814587 is actively recruiting participants. Contact the research team at sarah.mcneil@utsouthwestern.edu for enrollment information.
Where is the NCT06814587 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06814587 clinical trial?
NCT06814587 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Gaurav Sharma, PhD, MBA at University of Texas Southwestern Medical Center. The trial plans to enroll 15 participants.