Heart Bypass Surgery Clinical Trials

Clinical trials related to Heart Bypass Surgery Procedure

Hyperpolarized 13C Pyruvate-MRI and FDG-PET in a Single Exam for the Prognosis of Ischemic Cardiomyopathy

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

This prospective, non-blinded, single-center, translational research study aims to validate a multimodal advanced imaging exam for cardiac viability. The protocol utilizes three distinct imaging modalities: Single Photon Emission Computed Tomography Myocardial Perfusion Imaging (SPECT MPI), 18F-fluorodeoxyglucose positron emission tomography (FDG-PET), and Hyperpolarized Carbon-13 (HP-13C) Pyruvate Magnetic Resonance Imaging (MRI). Under this protocol, the SPECT MPI and FDG-PET exams will be used in combination to comprehensively assess myocardial viability. Concurrently, the HP-13C Pyruvate MRI will be utilized to provide additional insights into myocardial metabolism. The study will evaluate healthy volunteers to establish baseline parameters and patients with ischemic cardiomyopathy (ICM) before and after surgical revascularization.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: t
View:

• Male or Female, age 18-80 years. Patient scheduled for Coronary Artery Bypass Surgery as standard of care therapy per clinical guidelines.

• Presence of 1 or more stenotic coronary artery vessels. Left Ventricular Ejection Fraction (LVEF) ≤ 40%, or clinical indication for myocardial viability assessment.

• Able to tolerate FDG PET/MRI protocol and preparation (e.g., fasting state, glucose regulation).

• Medication use within 24 hours of the scan is allowed and will be reported. Negative pregnancy test for females of childbearing age (on the day of scanning).

• No known contraindications to 3T MRI, SPECT MPI, or FDG PET.

• Male or Female, age 18-80 years. No history of coronary artery disease or diabetes. Eligible for 3T MRI, SPECT, and FDG-PET. Negative pregnancy test for females of childbearing age (on the day of scanning).

Locations
United States
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Sarah McNeil, RN
sarah.mcneil@utsouthwestern.edu
214-645-7700
Backup
Cesia Rodriguez Gongora, RN
cesia.rodriguezgongora@utsouthwestern.edu
214/645-7739
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 15
Treatments
Healthy Control Group (H)
1.1. Group Description This cohort consists of healthy individuals (n=6) with normal left ventricular ejection fraction (LVEF \>50%), no history of coronary artery disease, and no metabolic disorders. Participants will undergo a single session of hyperpolarized 13C pyruvate MRI (HP-13C MRI) and 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) to establish baseline myocardial metabolic and viability parameters.
Pre-CABG Ischemic Cardiomyopathy (Pre-CABG ICM)
2.1. Group Description This cohort includes patients with ischemic cardiomyopathy (n=6) scheduled for coronary artery bypass grafting (CABG) with LVEF \<35%. Participants will undergo preoperative HP-13C MRI and FDG-PET to assess myocardial metabolism and viability prior to revascularization.
Post-CABG Follow-up (Post-CABG ICM)
3.1. Group Description This cohort consists of patients post-CABG (n=12), imaged at two follow-up time points: 4-6 months (n=6) and 10-12 months (n=6) after surgery. Participants will undergo repeat HP-13C MRI and FDG-PET to evaluate longitudinal metabolic changes and myocardial functional recovery following revascularization.
Sponsors
Collaborators: American Heart Association
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov