Heart scans with XTR003 and 18F-FDG to check living heart muscle in ischemic cardiomyopathy
Compares two PET scan methods that check heart muscle health in ischemic cardiomyopathy.
Plain-language title generated from the registry record
Registry title: PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection and 18F-FDG to Assess Myocardial Viability in Ischemic Cardiomyopathy
Key facts
- Where
- Beijing and Tianjin, ChinaSee the 3 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07443696, who can take part
Where in China
- Beijing Anzhen Hospital, Capital Medical UniversityBeijing, ChinaTaking people
- Beijing Chaoyang Hospital, Capital Medical UniversityBeijing, ChinaNot yet recruiting
- TEDA International Cardiovascular HospitalTianjin, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sinotau Pharmaceutical Group
- Trial code
- NCT07443696
- Record updated
- 2 March 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Open-Label, Parallel-Controlled Phase IIb Clinical Trial of PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection Integrated With 18F-FDG for the Assessment of Myocardial Viability in Patients With Ischemic Cardiomyopathy
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).
Inclusion: 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%; Assessed by a team of cardiac surgeons/operators as suitable for complete revascularization; Capable of effective communication with the investigators, able to understand and comply with the clinical study requirements, voluntarily participate in the study, and provide written informed consent after being fully informed.
Exclusion: Decompensated heart failure within 48 hours prior to enrollment; Contraindications to magnetic resonance imaging (MRI), such as claustrophobia or intracorporeal metallic implants; Significant occupational exposure to ionizing radiation (e.g., exceeding 50 mSv per year) or exposure to radioactive substances/ionizing radiation for therapeutic or research purposes within the past 10 years; Recent ST-segment elevation myocardial infarction (STEMI) within less than 4 weeks; Severe renal insufficiency; Severe hepatic insufficiency; Subjects with fever or active infectious diseases who are assessed by the investigator as unsuitable for study participation; Subjects with mental disorders or poor compliance; Left ventricular aneurysm; Judged by the investigator as unable to complete PET examination; Pregnant or lactating women; Other circumstances deemed by the investigator as unsuitable for trial participation.