Actively Recruiting
A Randomized, Open-Label, Parallel-Controlled Phase IIb Trial of XTR003 Injection Combined with 18F-FDG PET for Assessing Myocardial Viability in Ischemic Cardiomyopathy
Led by Sinotau Pharmaceutical Group · Updated on 2026-03-02
40
Participants Needed
3
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of XTR003 Injection combined with 18F-FDG for myocardial fatty-acid metabolic imaging in patients with ischemic cardiomyopathy. This Phase IIb, randomized, open-label study aims to explore the diagnostic and prognostic value of this imaging approach by comparing it with a glucose-loaded method. The study plans to enroll 40 to 60 patients and assess myocardial metabolic activity and viability using advanced imaging techniques. Participants will be randomly assigned to one of two groups: a fasting XTR003/18F-FDG PET group or a glucose-loaded 18F-FDG PET group. Both groups will undergo resting myocardial perfusion imaging combined with metabolic PET imaging to evaluate heart muscle activity and viability. Cardiac MRI and echocardiography will be used to assess heart function before and after complete revascularization within six months. A follow-up resting myocardial perfusion imaging will evaluate improvements in perfusion abnormalities. During the study, participants will have imaging tests, including PET scans, cardiac MRI, and echocardiography, at baseline and after treatment. Researchers will monitor changes in heart function and myocardial viability, as well as adverse cardiac events over a six-month follow-up period. The main outcomes measured include sensitivity and specificity of the imaging methods and changes in heart function and clinical classification. The study duration for each participant is six months.
CONDITIONS
Brief 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, any gender
- Diagnosed with ischemic cardiomyopathy
- Significant coronary artery disease
- Left ventricular systolic dysfunction with ejection fraction >20% to ≤40%
- Assessed as suitable for complete revascularization by cardiac surgery team
- Able to communicate, understand study requirements, and provide informed consent
You will not qualify if you...
- Decompensated heart failure within 48 hours before enrollment
- ST-segment elevation myocardial infarction within past 4 weeks
- Presence of left ventricular aneurysm
- Unable to complete PET examination as judged by investigator
- Severe kidney or liver insufficiency
- Fever or active infection unsuitable for participation
- Pregnant or breastfeeding women
- Contraindications to MRI such as claustrophobia or metal implants
- Mental disorders or poor compliance
- Significant exposure to ionizing radiation exceeding 50 mSv per year or within past 10 years
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1
Participants undergo fasting XTR003 / ¹⁸F-FDG PET myocardial metabolic imaging or glucose-modulated ¹⁸F-FDG PET myocardial metabolic imaging to assess myocardial viability.
1 visit (in-person)
Duration - 6 months
Participants are monitored for changes in myocardial perfusion-metabolism imaging parameters, left ventricular function parameters, NYHA classification, and major adverse cardiac events over 6 months.
Multiple visits over 6 months
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
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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