NCT06047028

Prognostic Value of Hyperpolarized 13C MRI for Clinical Myocardial Viability

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

PRIMARY OBJECTIVES: The principal aim of this investigation is to employ noninvasive techniques for the in vivo assessment of segmental myocardial metabolism. This will be achieved by measuring the hyperpolarized (HP) 13C bicarbonate-to-lactate (bic/lac) ratio in patients scheduled for coronary artery bypass surgery (CABG), both preoperatively and 4-6 months postoperatively. These findings will be compared with a control group of healthy subjects to establish normal metabolic values. SECONDARY OBJECTIVES: In addition to the primary objectives, this study seeks to accomplish the following secondary objectives: 1. To ascertain the safety profile and tolerability of HP \[1-13C\] pyruvate administration during the MRI exam. 2. To evaluate the reproducibility of the HP 13C MRI data if the optional second injection of hyperpolarized 13C pyruvate is administered. EXPLORATORY OBJECTIVES: In pursuit of further insights, this research also aims to explore the following: 1. Investigate potential associations between blood measurements for pyruvate, triglycerides, free fatty acids, and insulin levels with the bicarbonate/lactate ratio within the myocardium. 2. Explore correlations between segmental myocardial metabolism (the bic/lac ratio) and mechanical function, such as echocardiographic measurements of wall motion.

Conditions

• Coronary Artery Disease
• Ischemic Heart Disease (IHD)
• Myocardial Viability

Timeline

• Start date: 2023-06-30
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2023-09-21
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States