NCT06814587Recruiting
Hyperpolarized 13C Pyruvate-MRI and FDG-PET in a Single Exam for the Prognosis of Ischemic Cardiomyopathy
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 15 (estimated)
- First submitted
- 30 Jan 2025
- Start date
- 1 Jul 2024
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT06814587
What you commit to
- Study type: Observational
- Planned participants: 15
- From 1 Jul 2024 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior myocardial infarction with transmural scar \> 50% (based on prior imaging or clinical history).
- Contraindications to MRI (e.g., metallic implants, claustrophobia), SPECT MPI, or FDG-PET.
Other illness
- History of coronary artery disease, diabetes, or other medical conditions deemed exclusionary by the study team.
Lab values
- 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).
- 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.
Age
- Male or female, age \< 18 or \> 80 years of age. Patients not scheduled for CABG or those without confirmed coronary artery disease (CAD).
Other
- Positive pregnancy test or females currently breastfeeding (on the day of scanning).
- Healthy Volunteer Cohort
- Positive pregnancy test or females currently breastfeeding (on the day of scanning).
Who the study is looking for
- 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.
- 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).
Criteria the registry did not label
- 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
Age in the registry: 20 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.