Prognostic Value of Hyperpolarized 13C MRI for Clinical Myocardial Viability
Purpose
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
Eligibility
- Eligible Ages
- Between 20 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Criteria
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:
- 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.
- 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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
Recruiting Locations
Dallas, Texas 75390
More Details
- Status
- Recruiting
- Sponsor
- University of Texas Southwestern Medical Center
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: 1. To ascertain the safety profile and tolerability of HP [1-13C] pyruvate administration during the MRI exam. 2. 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: 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 correlations between segmental myocardial metabolism (the bic/lac ratio) and mechanical function, such as echocardiographic measurements of wall motion.