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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting XTR003/ ¹⁸F-FDG PET | Experimental | Fasting XTR003 and ¹⁸F-FDG PET combined with myocardial metabolic imaging |
|
| Glucose-modulated ¹⁸F-FDG PET | Active Comparator | Glucose-modulated ¹⁸F-FDG PET Myocardial Metabolic Imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging | Drug | Fasting XTR003 / ¹⁸F-FDG PET myocardial metabolic imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| the sensitivity and specificity of the experimental group and control group | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial perfusion-metabolism imaging parameters (segmental level) | include the following three items:
| 6 months |
| Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Liu | Contact | +86-18101131863 | tao.liu1@sinotau.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
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Randomized and Open-Label
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| Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging | Drug | Glucose loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging |
|
Left ventricular ejection fraction (LVEF, %) |
| 6 months |
| Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization | Left ventricular end-diastolic diameter (LVEDD) | 6 months |
| Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization | Left ventricular end-systolic diameter (LVESD) | 6 months |
| Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization | Left ventricular end-diastolic volume (LVEDV, mL) | 6 months |
| Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization | Left ventricular end-systolic volume (LVESV, mL) | 6 months |
| 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 |
| Beijing Chaoyang Hospital, Capital Medical University | Not yet recruiting | Beijing | China |
| TEDA International Cardiovascular Hospital | Not yet recruiting | Tianjin | China |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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