'Prognostic Value of Hyperpolarized 13C MRI for Clinical Myocardial Viability

Myocardial Perfusion Imaging Clinical Trial

Official title: 'Prognostic Value of Hyperpolarized 13C MRI for Clinical Myocardial Viability

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

PRIMARY OBJECTIVES:

The principal aim of this investigation is to employ noninvasive techniques for in vivo detection of viable myocardial tissue. This will be achieved through the assessment of the HP 13C bicarbonate-to-lactate ratio, denoted as the bicarbonate/pyruvate intensity, in patients diagnosed with ischemic cardiomyopathy both before and after undergoing coronary artery bypass surgery (CABG). The obtained data will be compared with a control group composed of healthy subjects.

SECONDARY OBJECTIVES:

In addition to the primary objectives, this study seeks to accomplish the following secondary objectives:

1. To ascertain the safety profile of HP 13C pyruvate administration in patients with advanced ischemic cardiomyopathy.

2. To evaluate the reproducibility of HP 13C pyruvate MRI scans during the second injection of HP 13C pyruvate.

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 any correlations between myocardial wall motion and the bicarbonate/lactate ratio within the myocardium. ;

Related Conditions & MeSH terms

• Myocardial Perfusion Imaging
• Ventricular Function, Left

• NCT number: NCT06047028
• Study type: Observational
• Source: University of Texas Southwestern Medical Center
• Status: Recruiting
• Start date: June 30, 2023
• Completion date: August 2024