Heart Failure, Ischemic Cardiomyopathy
Conditions
Keywords
18F-FDG, XTR003, position emission tomography, myocardial metabolic imaging, myocardial viability, ischemic cardiomyopathy
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).
Interventions
DRUGFasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging
Fasting XTR003 / ¹⁸F-FDG PET myocardial metabolic imaging
DRUGGlucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging
Glucose loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging
Sponsors
Sinotau Pharmaceutical Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Randomized and Open-Label
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the sensitivity and specificity of the experimental group and control group | 6 months | Using the recoverable left-ventricular wall motion abnormality at 6 months post full revascularization as the reference standard to study the sensitivity and specificity of myocardial viability for predicting functional recovery in the experimental group and control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial perfusion-metabolism imaging parameters (segmental level) | 6 months | include the following three items: 1. summed rest score 2. summed FDG score 3. summed rest score minus summed FDG score |
| Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization | 6 months | Left ventricular ejection fraction (LVEF, %) |
| Changes in New York Heart Association Functional Classification (NYHA) | 6 months | — |
| Duration Required for PET Myocardial Metabolic Imaging in the Two Groups (min) | day 1 | — |
| PET Myocardial Metabolic Imaging Quality | day 1 | — |
| Resting MPI of perfusion abnormality | 6 months | — |
| Major adverse cardiac events (MACE) | 6 months | — |
Countries
China
Contacts
CONTACTTao Liu
Outcome results
None listed