Prognostic Value of Hyperpolarized 13C MRI for Clinical Myocardial Viability

NCT06047028 | Recruiting

• 2 other identifiers: STU-2020-0953Velos# 31471
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Bicarbonate-to-Lactate Ratio in Healthy Control Subjects

  Assessment of normal segmental myocardial metabolism by measuring the ratio of hyperpolarized (HP) \[13C\]-bicarbonate to HP \[1-13C\]lactate (bic/lac ratio). This is obtained during an HP-13C MRI utilizing \[1-13C\] pyruvate to establish baseline normal values for healthy subjects.

  Baseline (Day 1 of imaging)

• Bicarbonate-to-Lactate Ratio in Preoperative CAD Patients

  Assessment of segmental myocardial metabolism and mechanical function in patients scheduled for coronary artery bypass surgery. The bic/lac ratio is measured using HP-13C MRI to identify abnormal cardiac metabolism and impaired oxidative function. These metabolic findings will be correlated with echocardiographic measurements of wall motion and viability studies obtained by the referring cardiologist.

  Preoperative imaging day

• Change in Bicarbonate-to-Lactate Ratio Post-Surgery

  Follow-up assessment of segmental myocardial metabolism to evaluate the remodeling of cardiac metabolism as a consequence of surgery. The bic/lac ratio is measured using HP-13C MRI to determine if the ratio has increased compared to the patient's preoperative baseline, indicating improved oxidative function.

  4-6 months after surgical coronary revascularization

Study Arms (3)

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.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential human subjects will be identified and referred by cardiothoracic surgeons (Drs. Peltz or Jessen.) and their clinical team will discuss the opportunity to participate with their patients or potential subjects. A research nurse from the Cardiovascular and Thoracic Surgery Clinical Trials office will directly contact the subject to further discuss study participation, otherwise, the details and contact information of clinical study coordinator will be provided for prescreening. Once the study candidate expresses interest, details will be forwarded to the Advanced Imaging Research Center and an appointment will be scheduled for the 13C metabolic imaging exam. All NIH and UTSWMC regulations related to confidentiality, recruitment practices, etc., will apply. All patients will be reviewed for medical history, demographics, subject eligibility criteria, MRI screening form, informed consent, and pregnancy test for females of child-bearing potential.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• American Heart Association: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Gaurav Sharma, PhD.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah S McNeil

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 21, 2023
• Study Start: June 30, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)