Ischemic Heart Disease (IHD) Clinical Trial
Official title:
Exploratory Application of XTR003 as a Novel PET Myocardial Fatty Acid Metabolism Imaging Agent for the Detection of Viable Myocardium
The study was designed to explore the clinical feasibility of XTR003, a PET myocardial fatty-acid tracer, for the detection of viable myocardium in patients with ischemic heart disease (IHD).
The incidence of IHD is increasing in China and globally. However, the 18F-FDG-PET patient preparation protocols present challenges in certain patients such as patients with type I and II Diabetes Mellitus. XTR003 is a PET fatty-acid analog used in the imaging of myocardial fatty-acid metabolism. The combination of fasting XTR003/18F-FDG PET imaging may overcome the shortness of glucose-loaded 18F-FDG PET imaging protocol and effectively identify viable myocardium. This is an exploratory, single-arm, open-label, phase II clinical study with the following objectives: 1. To explore the clinical feasibility of XTR003 for the detection of viable myocardium in patients with NSTEMI, old myocardial infarction, or total occlusions of coronary arteries. 2. To evaluate the safety and adverse events incidence of XTR003 in patients with known IHD. 3. To evaluate the sensitivity and specificity of fasting 18F-FDG/XTR003 PET combining imaging in detecting viable myocardium. ;