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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: t
View:

• 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.

Locations
United States
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Sarah S McNeil
sarah.mcneil@utsouthwestern.edu
214-645-7700
Time Frame
Start Date: 2023-06-30
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 30
Related Therapeutic Areas
Sponsors
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov