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| ID | Type | Description | Link |
|---|---|---|---|
| Velos# 31471 | Other Identifier | University of Texas Southwestern Medical Center |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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:
EXPLORATORY OBJECTIVES:
In pursuit of further insights, this research also aims to explore the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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The eligibility criteria for this feasibility study are designed to select participants who will provide valuable insights into myocardial metabolism using HP-13C MRI in various contexts related to ischemic heart failure. These criteria aim to ensure that the study population is diverse and representative of the patient groups under investigation.
Inclusion/Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah S McNeil | Contact | 214-645-7700 | sarah.mcneil@utsouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gaurav Sharma, PhD. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |