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

NCT ID: NCT06047028

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2026-06-30

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.

Detailed 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.

Conditions

Ventricular Function, Left; Myocardial Perfusion Imaging

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Exclusion Criteria

• Age range: 40 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Gaurav Sharma

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaurav Sharma, PhD.

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sarah S McNeil

Role: CONTACT

sarah.mcneil@utsouthwestern.edu

214-645-7700

Facility Contacts

Sarah S McNeil, RN

Role: primary

sarah.mcneil@utsouthwestern.edu

214-645-7700

Other Identifiers

Velos# 31471

Identifier Type: OTHER

Identifier Source: secondary_id

STU-2020-0953

Identifier Type: -

Identifier Source: org_study_id