PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection and 18F-FDG to Assess Myocardial Viability in Ischemic Cardiomyopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging, Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging.
- Who it may be relevant to
- Registry conditions: Ischemic Cardiomyopathy, Heart Failure. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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).
Interventions
- Drug Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging
Fasting XTR003 / ¹⁸F-FDG PET myocardial metabolic imaging - Drug Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging
Glucose loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging
Primary outcome measures
- the sensitivity and specificity of the experimental group and control group [Time frame: 6 months]
Secondary outcome measures (11)
- Myocardial perfusion-metabolism imaging parameters (segmental level) [Time frame: 6 months]
- Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization [Time frame: 6 months]
- Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization [Time frame: 6 months]
- Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization [Time frame: 6 months]
- Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization [Time frame: 6 months]
- Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization [Time frame: 6 months]
- Changes in New York Heart Association Functional Classification (NYHA) [Time frame: 6 months]
- Duration Required for PET Myocardial Metabolic Imaging in the Two Groups (min) [Time frame: day 1]
- PET Myocardial Metabolic Imaging Quality [Time frame: day 1]
- Resting MPI of perfusion abnormality [Time frame: 6 months]
- Major adverse cardiac events (MACE) [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Decompensated heart failure within 48 hours prior to enrollment.
- Recent ST-segment elevation myocardial infarction (STEMI) within less than 4 weeks.
- Left ventricular aneurysm.
- Judged by the investigator as unable to complete PET examination.
- Severe renal insufficiency.
- Severe hepatic insufficiency.
- Subjects with fever or active infectious diseases who are assessed by the investigator as unsuitable for study participation.
- Pregnant or lactating women.
- Contraindications to magnetic resonance imaging (MRI), such as claustrophobia or intracorporeal metallic implants.
- Subjects with mental disorders or poor compliance.
- 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.
- Other circumstances deemed by the investigator as unsuitable for trial participation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 3 centers
- Beijing Anzhen Hospital, Capital Medical University — Beijing
- Beijing Chaoyang Hospital, Capital Medical University — Beijing
- TEDA International Cardiovascular Hospital — Tianjin
Identifiers
NCT: NCT07443696 · STB-XTR003-202