Evaluating heart tissue viability using advanced MRI techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the prognostic value of hyperpolarized 13C MRI in detecting viable myocardial tissue in patients with ischemic cardiomyopathy. By measuring the bicarbonate-to-lactate ratio, the study seeks to refine patient selection for coronary artery bypass surgery (CABG) and compare results with a control group of healthy subjects. The study also evaluates the safety of HP 13C pyruvate administration and the reproducibility of MRI scans. This innovative approach avoids ionizing radiation and provides critical insights into cardiac function.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Gaurav Sharma, PhD. — University of Texas Southwestern Medical Center
• Study coordinator: Sarah S McNeil
• Email: sarah.mcneil@utsouthwestern.edu
• Phone: 214-645-7700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.