NCT07443696 PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection and 18F-FDG to Assess Myocardial Viability in Ischemic Cardiomyopathy
| NCT ID | NCT07443696 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sinotau Pharmaceutical Group |
| Condition | Ischemic Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2025-12-18 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 to 85 years, regardless of gender. 2. Diagnosed with ischemic cardiomyopathy (ICM). 3. significant coronary artery disease (CAD). 4. Left ventricular systolic dysfunction, with LVEF ranging from \>20% to ≤40% 5. Assessed by a team of cardiac surgeons/operators as suitable for complete revascularization. 6. 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 Criteria: 1. Decompensated heart failure within 48 hours prior to enrollment. 2. Recent ST-segment elevation myocardial infarction (STEMI) within less than 4 weeks. 3. Left ventricular aneurysm. 4. Judged by the investigator as unable to complete PET examination. 5. Severe renal insufficiency. 6. Severe hepatic insufficiency. 7. Subjects with fever or active infectious diseases who are assessed by the investigator as unsuitable for study participation. 8. Pregnant or lactating women. 9. Contraindications to magnetic resonance imaging (MRI), such as claustrophobia or intracorporeal metallic implants. 10. Subjects with mental disorders or poor compliance. 11. 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. 12. Other circumstances deemed by the investigator as unsuitable for trial participation.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07443696 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Ischemic Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07443696 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07443696 currently recruiting?
Yes, NCT07443696 is actively recruiting participants. Contact the research team at tao.liu1@sinotau.com for enrollment information.
Where is the NCT07443696 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Tianjin, China.
Who is sponsoring the NCT07443696 clinical trial?
NCT07443696 is sponsored by Sinotau Pharmaceutical Group. The trial plans to enroll 40 participants.