Prognostic Value of Hyperpolarized 13C MRI for Clinical Myocardial Viability
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-80
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Age range: 20 to 80 years
Sex: Random allocation
Preoperative patients with LVEF < 0.35
Healthy subjects with LVEF > 0.50
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 3 trial groupsGroup A: Healthy Control Subjects
Group B: Preoperative CAD Patients
Group C: Postoperative CAD Patients
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Day 1 of imaging)2
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.
Time frame
Preoperative imaging day3
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.
Time frame
4-6 months after surgical coronary revascularizationSponsors and contacts
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University of Texas Southwestern Medical Center
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov