Coronary Artery DiseaseNCT06047028
Prognostic Value of Hyperpolarized 13C MRI for Clinical Myocardial Viability
An observational study of Coronary Artery Disease and Ischemic Heart Disease (IHD), run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Ischemic Heart Disease (IHD), Myocardial Viability
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 30 Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Sarah S McNeil, RN, 214-645-7700, sarah.mcneil@utsouthwestern.edu
About this study
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.
Read the 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:
- To ascertain the safety profile and tolerability of HP [1-13C] pyruvate administration during the MRI exam.
- 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:
- Investigate potential associations between blood measurements for pyruvate, triglycerides, free fatty acids, and insulin levels with the bicarbonate/lactate ratio within the myocardium.
- Explore correlations between segmental myocardial metabolism (the bic/lac ratio) and mechanical function, such as echocardiographic measurements of wall motion.
- Keywords
- Hyperpolarized 13C MRI, Coronary Artery Bypass Surgery, Segmental myocardial metabolism, Mitochondrial function
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4-6 months after surgical coronary revascularization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jul 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Gaurav Sharma, University of Texas Southwestern Medical Center
- Investigators
- Gaurav Sharma, PhD., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047028
- Sponsor's protocol ID
- STU-2020-0953
- Other IDs
- Velos# 31471
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No