Actively Recruiting
PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection and 18F-FDG to Assess Myocardial Viability in Ischemic Cardiomyopathy
Led by Sinotau Pharmaceutical Group · Updated on 2026-03-02
40
Participants Needed
3
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection and 18F-FDG to Assess Myocardial Viability in Ischemic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 85 years, regardless of gender.
- Diagnosed with ischemic cardiomyopathy (ICM).
- Have significant coronary artery disease (CAD).
- Left ventricular systolic dysfunction with LVEF greater than 20% and up to 40%.
- Considered suitable for complete revascularization by cardiac surgeons or operators.
- Able to communicate effectively, understand and agree to study requirements, voluntarily participate, and provide written informed consent after full information.
You will not qualify if you...
- Decompensated heart failure within 48 hours before enrollment.
- Recent ST-segment elevation myocardial infarction (STEMI) less than 4 weeks ago.
- Presence of left ventricular aneurysm.
- Unable to complete PET examination as judged by the investigator.
- Severe kidney failure.
- Severe liver failure.
- Fever or active infections deemed unsuitable for study participation by the investigator.
- Pregnant or breastfeeding women.
- Contraindications to MRI such as claustrophobia or metallic implants inside the body.
- Mental disorders or poor compliance.
- Significant occupational exposure to ionizing radiation (over 50 mSv per year) or exposure to radioactive substances/ionizing radiation for therapy or research in the past 10 years.
- Other conditions the investigator considers unsuitable for participation.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
2
Beijing Chaoyang Hospital, Capital Medical University
Beijing, China
Not Yet Recruiting
3
TEDA International Cardiovascular Hospital
Tianjin, China
Not Yet Recruiting
Research Team
T
Tao Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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