This is a prospective, multicenter, randomized, open-label, parallel-controlled Phase IIb study to investigate the diagnostic-prognostic utility of XTR003 Injection integrated with 18F-FDG as an exploratory clinical trial. A total of 40-60 patients will be enrolled and randomized into two study groups as: fasting XTR003/18F-FDG group and glucose-loaded group at a 1:1 ratio. Each group will receive resting myocardial perfusion imaging (MPI) combined with metabolic PET imaging to evaluate myocardial metabolic activity and myocardial viability. Segmental perfusion abnormality, metabolic activity and myocardial viability will be analyzed according to the standard approaches in Nuclear Cardiology. Regional and global left ventricular function will be assessed with cardiac MRI and echocardiography prior to and post the completion of full revascularization within 6-month time point. A repeated resting MPI will also be performed to assess the improvement of perfusion abnormality.
All study subjects will undergo 6 months follow-up for major adverse cardiac events (MACE).
Aged 18 to 85 years, regardless of gender.
Diagnosed with ischemic cardiomyopathy (ICM).
significant coronary artery disease (CAD).
Left ventricular systolic dysfunction, with LVEF ranging from >20% to ≤40%
Decompensated heart failure within 48 hours prior to enrollment.
Recent ST-segment elevation myocardial infarction (STEMI) within less than 4 weeks.
Left ventricular aneurysm.
Judged by the investigator as unable to complete PET examination.
Parallel
Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging
DrugFasting XTR003 / ¹⁸F-FDG PET myocardial metabolic imaging
Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging
DrugGlucose loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging
the sensitivity and specificity of the experimental group and control group
Using the recoverable left-ventricular wall motion abnormality at 6 months post full revascularization as the reference standard to study the sensitivity and specificity of myocardial viability for predicting functional recovery in the experimental group and control group.
Myocardial perfusion-metabolism imaging parameters (segmental level)
include the following three items: 1. summed rest score 2. summed FDG score 3. summed rest score minus summed FDG score
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization
Left ventricular ejection fraction (LVEF, %)
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization
Left ventricular end-diastolic diameter (LVEDD)
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization
Left ventricular end-systolic diameter (LVESD)
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