NCT06047028 Prognostic Value of Hyperpolarized 13C MRI for Clinical Myocardial Viability
| NCT ID | NCT06047028 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-06-30 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2023-06-30 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Gaurav Sharma, PhD.
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT06047028 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06047028 currently recruiting?
Yes, NCT06047028 is actively recruiting participants. Contact the research team at sarah.mcneil@utsouthwestern.edu for enrollment information.
Where is the NCT06047028 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06047028 clinical trial?
NCT06047028 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Gaurav Sharma, PhD. at University of Texas Southwestern Medical Center. The trial plans to enroll 30 participants.