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Search / Trial NCT06047028

'Prognostic Value of Hyperpolarized 13C MRI for Clinical Myocardial Viability

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Sep 13, 2023

Trial Information

Current as of August 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring a new imaging technique called Hyperpolarized 13C MRI to help doctors better understand heart function in patients with heart failure due to coronary artery disease. The goal is to identify which patients are suitable for bypass surgery without using harmful radiation. This advanced method looks at how the heart uses certain molecules, specifically bicarbonate and lactic acid, to assess its health and performance, potentially leading to more accurate diagnoses and better treatment decisions.

To participate in the study, individuals should be between 40 and 80 years old and have specific heart conditions. For example, patients preparing for surgery should have a left ventricular ejection fraction (LVEF) of less than 0.35, indicating weakened heart function. Healthy volunteers, on the other hand, should have an LVEF greater than 0.50. Participants can expect to undergo the Hyperpolarized 13C MRI scan, which is a non-invasive procedure, and their health information will be collected to provide a better understanding of heart metabolism. This study aims to include a diverse group of participants to ensure the findings are relevant to various patients with heart issues.

Gender

ALL

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: 40 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.

About University Of Texas Southwestern Medical Center

The University of Texas Southwestern Medical Center is a leading academic medical institution dedicated to advancing healthcare through innovative research, education, and clinical excellence. With a strong emphasis on translational medicine, the center conducts cutting-edge clinical trials aimed at developing novel therapies and improving patient outcomes across a wide range of diseases. Its multidisciplinary approach leverages a collaborative network of renowned faculty, state-of-the-art facilities, and a commitment to ethical research practices, positioning UT Southwestern at the forefront of medical discovery and patient care.

Locations

Dallas, Texas, United States

Patients applied

0 patients applied

Trial Officials

Gaurav Sharma, PhD.

Principal Investigator

UT Southwestern Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported