Status:
RECRUITING
'Prognostic Value of Hyperpolarized 13C MRI for Clinical Myocardial Viability
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Ventricular Function, Left
Myocardial Perfusion Imaging
Eligibility:
All Genders
40-80 years
Brief 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...
Detailed Description
PRIMARY OBJECTIVES: The principal aim of this investigation is to employ noninvasive techniques for in vivo detection of viable myocardial tissue. This will be achieved through the assessment of the ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06047028
Start Date
June 30 2023
End Date
June 30 2026
Last Update
January 31 2025
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390