RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-06-30
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06047028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Age range: 40 to 80 years
  2. * Sex: Random allocation
  3. * Left ventricular ejection fraction (LVEF):
  4. * Preoperative patients with LVEF \< 0.35
  5. * Healthy subjects with LVEF \> 0.50
  6. * Clinical history:
  7. * Previous myocardial infarction (MI): Excluded for healthy subjects, included for preoperative patients.
  8. * Diabetes mellitus: Excluded for all participants.
  9. * Hypertension: Included for all participants
  10. * Mean blood pressure: Systolic \< 140 mm Hg and Diastolic \< 90 mm Hg for all participants
  11. * Mean heart rate: 78 beats/min for all participants
  12. * Current smoker status: Included but will be reported.
  13. * Medication use within 24 hours: Use will be reported.
  14. * Coronary artery bypass surgery history: Excluded for healthy subjects, included for preoperative patients.
  15. * Infarct type and location: Excluded for healthy subjects, included for preoperative patients with various Q-wave infarct types and locations.
  16. * Number of diseased coronary vessels: Excluded for healthy subjects, included for preoperative patients with at least one diseased vessel.
  17. * Additional medical history and clinical data: Variations in data availability are expected based on the practices of referring physicians and will be documented.

Contacts and Locations

Principal Investigator

Gaurav Sharma, PhD.
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Gaurav Sharma, PhD., PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-30
Study Completion Date2024-12

Study Record Updates

Study Start Date2023-06-30
Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

  • Ventricular Function, Left
  • Myocardial Perfusion Imaging