Evaluating heart tissue viability using advanced MRI techniques

Prognostic Value of Hyperpolarized 13C MRI for Clinical Myocardial Viability

This study is testing a new MRI technique to see if it can help doctors find healthy heart tissue in patients with ischemic cardiomyopathy so they can better decide who needs heart surgery.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (other)
• Drugs / interventions: radiation
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT06047028 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the prognostic value of hyperpolarized 13C MRI in detecting viable myocardial tissue in patients with ischemic cardiomyopathy. By measuring the bicarbonate-to-lactate ratio, the study seeks to refine patient selection for coronary artery bypass surgery (CABG) and compare results with a control group of healthy subjects. The study also evaluates the safety of HP 13C pyruvate administration and the reproducibility of MRI scans. This innovative approach avoids ionizing radiation and provides critical insights into cardiac function.

Who should consider this trial

Good fit: Ideal candidates include patients aged 40 to 80 with ischemic cardiomyopathy and a left ventricular ejection fraction (LVEF) of less than 0.35.

Not a fit: Patients with diabetes mellitus or those with a healthy heart (LVEF greater than 0.50) may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the precision of diagnosing myocardial viability, leading to better patient outcomes in heart failure management.

How similar studies have performed: While the use of hyperpolarized 13C MRI is innovative, similar imaging techniques have shown promise in other studies, suggesting potential for success.

Eligibility criteria

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.

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. — University of Texas Southwestern Medical Center
• Study coordinator: Sarah S McNeil

Conditions: Coronary Artery Disease, Ischemic Heart Disease, Myocardial Viability, Hyperpolarized 13C MRI, Coronary Artery Bypass Surgery, Segmental myocardial metabolism, Mitochondrial function