A Randomized, Open-Label, Parallel-Controlled Phase IIb Trial of XTR003 Injection Combined with 18F-FDG PET for Assessing Myocardial Viability in Ischemic Cardiomyopathy

What this Trial Is About

Researchers are evaluating the use of XTR003 Injection combined with 18F-FDG for myocardial fatty-acid metabolic imaging in patients with ischemic cardiomyopathy. This Phase IIb, randomized, open-label study aims to explore the diagnostic and prognostic value of this imaging approach by comparing it with a glucose-loaded method. The study plans to enroll 40 to 60 patients and assess myocardial metabolic activity and viability using advanced imaging techniques. Participants will be randomly assigned to one of two groups a fasting XTR00318F-FDG PET group or a glucose-loaded 18F-FDG PET group. Both groups will undergo resting myocardial perfusion imaging combined with metabolic PET imaging to evaluate heart muscle activity and viability. Cardiac MRI and echocardiography will be used to assess heart function before and after complete revascularization within six months. A follow-up resting myocardial perfusion imaging will evaluate improvements in perfusion abnormalities. During the study, participants will have imaging tests, including PET scans, cardiac MRI, and echocardiography, at baseline and after treatment. Researchers will monitor changes in heart function and myocardial viability, as well as adverse cardiac events over a six-month follow-up period. The main outcomes measured include sensitivity and specificity of the imaging methods and changes in heart function and clinical classification. The study duration for each participant is six months.

PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection and 18F-FDG to Assess Myocardial Viability in Ischemic Cardiomyopathy