Recruiting

Hyperpolarized 13C MRI

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06047028

Conditions

Coronary Artery Disease

Ischemic Heart Disease (IHD)

Myocardial Viability

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Heart failure due to coronary artery disease represents a significant cause of mortality. The detection of patients eligible for bypass surgery is a pivotal concern. Nevertheless, the optimal approach for patient selection based on conventional imaging scans remains unclear. The proposed method (Hyperpolarized 13C MRI) has gained extensive use in evaluating in vivo metabolism. This method avoids ionizing radiation and provides critical insights into cardiac function. The feasibility study aims to investigate this method for patient selection before bypass surgery. This innovative imaging technique facilitates the identification of two simple molecules, bicarbonate and lactic acid, produced at high rates by normal heart metabolism. Both bicarbonate and lactate originate from the same precursor molecule, pyruvate. The data generated from this study holds the potential to refine diagnostic precision.

Conditions

Coronary Artery Disease

Ischemic Heart Disease (IHD)

Myocardial Viability

Study ID

NCT06047028

Start date

Jun 30, 2023

Status verified date

Feb, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

The eligibility criteria for this feasibility study are designed to select participants who will provide valuable insights into myocardial metabolism using HP-13C MRI in various contexts related to ischemic heart failure. These criteria aim to ensure that the study population is diverse and representative of the patient groups under investigation.

Inclusion/Exclusion Criteria:

  • Age range: 20 to 80 years
  • Sex: Random allocation
  • Left ventricular ejection fraction (LVEF):
  • Preoperative patients with LVEF < 0.35
  • Healthy subjects with LVEF > 0.50
  • Clinical history:
  • Previous myocardial infarction (MI): Excluded for healthy subjects, included for preoperative patients.
  • Diabetes mellitus: Excluded for all participants.
  • Hypertension: Included for all participants
  • Mean blood pressure: Systolic < 140 mm Hg and Diastolic < 90 mm Hg for all participants
  • Mean heart rate: 78 beats/min for all participants
  • Current smoker status: Included but will be reported.
  • Medication use within 24 hours: Use will be reported.
  • Coronary artery bypass surgery history: Excluded for healthy subjects, included for preoperative patients.
  • Infarct type and location: Excluded for healthy subjects, included for preoperative patients with various Q-wave infarct types and locations.
  • Number of diseased coronary vessels: Excluded for healthy subjects, included for preoperative patients with at least one diseased vessel.
  • Additional medical history and clinical data: Variations in data availability are expected based on the practices of referring physicians and will be documented.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Control Subjects

Healthy volunteers (male or female, aged 20-80 years) who are eligible for a 3T MRI. They must have no history of coronary artery disease, diabetes, or other exclusionary medical diagnoses.

Preoperative CAD Patients

Male or female patients (aged 20-80 years) who are scheduled for Coronary Artery Bypass Surgery as standard of care. These patients have 1, 2, or more stenotic coronary vessels and are eligible for a 3T MRI.

Postoperative CAD Patients

The same population of patients from the preoperative group undergoing a follow-up evaluation 4-6 months after their surgical coronary revascularization.

Primary outcome measure

  • Bicarbonate-to-Lactate Ratio in Healthy Control Subjects [ Time Frame: Baseline (Day 1 of imaging) ]
  • Bicarbonate-to-Lactate Ratio in Preoperative CAD Patients [ Time Frame: Preoperative imaging day ]
  • Change in Bicarbonate-to-Lactate Ratio Post-Surgery [ Time Frame: 4-6 months after surgical coronary revascularization ]

Central Contacts and Locations

Central contacts

Sarah S McNeil

214-645-7700sarah.mcneil@utsouthwestern.edu

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Sarah S McNeil, RN

214-645-7700sarah.mcneil@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Hyperpolarized 13C MRI
  • Coronary Artery Bypass Surgery
  • Segmental myocardial metabolism
  • Mitochondrial function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-02-27.