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| Name | Class |
|---|---|
| Zhoukou Specialized Disease Hospital | UNKNOWN |
| Zhoukou Chuanhui District Hospital of Traditional Chinese Medicine | UNKNOWN |
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
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This study aims to evaluate the effectiveness of this facial image-based AI algorithm for screening CAD in high-risk community populations (specifically individuals with diabetes, hypertension, or aged over 65). The main objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic Test Cohort | Participants in this cohort undergo facial image-based AI screening. Subsequently, all participants in this group will undergo Coronary Computed Tomography Angiography (CCTA) as the gold standard reference to verify the diagnosis of CAD. All participants are followed up for 6 months. |
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| Real-world Observational Cohort | Participants in this cohort represent a real-world setting. They are followed up for 6 months to observe the natural detection rate of CAD and the occurrence of MACE outcomes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No Intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in Prevalence of CAD Between AI-Stratified High-Risk and Low-Risk Groups | Participants in the diagnostic test cohort are stratified into high-risk and low-risk groups using the AI screening strategy. Subsequently, all participants undergo Coronary Computed Tomography Angiography (CCTA). This outcome measures the difference in CAD prevalence between the two groups based on CCTA results. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The detection rate of CAD | The detection rate of CAD | 6 months |
| Incidence of Major Adverse Cardiovascular Events (MACE) | MACE is defined as a composite endpoint including all-cause death, myocardial infarction, and ischemia-driven coronary revascularization. The incidence of MACE will be compared between the diagnostic test cohort and the real-world observational cohort. |
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Inclusion Criteria:
Age >= 18 years.
Community high-risk population, defined as individuals meeting at least one of the following criteria:
Exclusion Criteria:
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The study population consists of community-dwelling residents identified as high-risk for Coronary Heart Disease (CHD). Participants are recruited from local community health centers and primary care settings. The cohort primarily comprises elderly individuals (aged > 65 years) and those with established cardiovascular risk factors, specifically diabetes mellitus and hypertension, who have not been previously diagnosed with CHD.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhe zheng, MD, PhD | Contact | +86-010-88398027 | zhengzhe@fuwai.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhoukou Chuanhui District Hospital of Traditional Chinese Medicine | Recruiting | Zhoukou | Henan | 466000 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D019066 | Facies |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Zhoukou Central Hospital | OTHER |
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| 6 months |
| Incidence of All-Cause Death | The number of participants who die from any cause during the follow-up period. | 6 months |
| Incidence of Myocardial Infarction | The number of participants who experience a myocardial infarction event, diagnosed based on standard clinical guidelines (e.g., symptoms, ECG changes, and troponin elevation). | 6 months |
| Incidence of Ischemia-Driven Coronary Revascularization | Defined as any percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) driven by ischemic symptoms or objective evidence of ischemia. | 6 months |
| Incidence of Screening-Driven Coronary Revascularization | Defined as coronary revascularization procedures (PCI or CABG) triggered by findings from screening examinations rather than acute clinical symptoms. | 6 months |
| Zhoukou Specialized Disease Hospital | Recruiting | Zhoukou | Henan | 466000 | China |
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| Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Not yet recruiting | Beijing | 100037 | China |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |