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NCT06047028Recruiting

Prognostic Value of Hyperpolarized 13C MRI for Clinical Myocardial Viability

Source: ClinicalTrials.gov · Last updated 11 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
30 (estimated)
First submitted
24 Aug 2023
Start date
1 Jul 2023
Primary completion date
30 Jun 2027
Lead sponsor
University of Texas Southwestern Medical Center
NCT number
NCT06047028

What you commit to

  • Study type: Observational
  • Planned participants: 30
  • From 1 Jul 2023 to the primary completion date, 30 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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.

Age in the registry: 20 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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SiteCityCountrySite status
University of Texas Southwestern Medical Center
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.