Combining advanced MRI and PET imaging for heart disease prognosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• μFR-guided Drug-Coated Balloon Angioplasty vs Angiography-guided Angioplasty in Coronary Artery Disease

  This trial tests whether using computational μFR guidance during drug-coated balloon angioplasty is better than standard angiography guidance for people with de novo coronary artery lesions.

  Recruiting Centro Cardiologico Monzino · Cosenza, CS and 3 other locations · NCT07917234

• Gastric Ultrasound Before CABG to See if Heart Function Changes Stomach Contents

  This study checks whether people with weaker heart function before elective CABG have different stomach contents seen on ultrasound.

  Recruiting Adiyaman University · Adıyaman · NCT07898215

• Can preoperative photon-counting CT help predict heart recovery after bypass surgery?

  This observational study tests whether a preoperative photon-counting CT can help predict heart function 3 months after coronary bypass surgery in adults with coronary artery disease.

  Recruiting Chinese PLA General Hospital · Beijing · NCT07883499

• Real-World Drug-Coated Balloon Angioplasty in Coronary Artery Disease

  This registry tests how drug-coated balloons perform in everyday clinical practice for adults with coronary artery disease undergoing PCI.

  Recruiting at 5 sites Hospital Arnau de Vilanova · Mexico City, Mexico City and 4 other locations · NCT07875088

• Predicting vasopressor needs after anesthesia in elective on-pump CABG using dynamic arterial elastance

  This study tests whether EaDyn measured after induction can help predict which patients will need vasopressors during elective on-pump CABG.

  Recruiting University of Gaziantep · Gaziantep · NCT07871201

• Intraoperative Pulse Pressure Variation and Postoperative Lactate Clearance in CABG Patients

  This study tests whether the amount a patient’s pulse pressure varies during surgery relates to how quickly lactate levels drop after CABG.

  Recruiting University of Gaziantep · Gaziantep · NCT07871188

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.