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The goal of this clinical trial is to learn if an AI-enabled stratified management system (SMART-CHD) can improve post-discharge outcomes in adults aged 18-45 with premature coronary artery disease. The main questions it aims to answer are:
Researchers will compare SMART-CHD to standard discharge management (verbal and printed instructions on medications, follow-up timelines and lifestyle advice) to see if the AI-driven platform leads to fewer adverse events and improved risk-factor profiles.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-Enabled Stratified Management Group | Experimental | Participants in the intervention group will use SMART-CHD alongside usual post-discharge care. |
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| Usual Post-Discharge Care Group | Active Comparator | Participants in the control group will receive usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-Enabled Stratified Management System | Combination Product | After discharge, participants install SMART-CHD, sync their EHR data, and complete a 10-minute orientation. They then use the app's OCR-assisted surveys to report lifestyle, lab, and event data, while paired wearables stream continuous vitals. AI voice calls and a CRC-managed WeChat group deliver reminders and support. The app's embedded predictive models stratify them into risk tiers and generate tier-specific follow-up schedules. Personalized lifestyle modification guidance, dietary plans, and medication adjustment recommendations are generated by the platform's module. Automated alerts and teleconsultation options are triggered upon detection of high-risk signs or abnormal results, ensuring timely clinical intervention and enhanced secondary prevention. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Composite Endpoint Events | A composite of all-cause death, myocardial infarction, stroke, and unplanned cardiovascular-related rehospitalization. | Assessed at 12 months post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Individual components of cardiac events | All-cause death, myocardial infarction, stroke, and unplanned cardiovascular-related rehospitalization | Assessed at 12 months post-discharge |
| LDL-C level |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gao Prof. Gao, MD, PhD | Contact | 010-88322413 | sophie_gao@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | Not yet recruiting | Hefei | Anhui | 230001 | China |
Individual participant data (IPD) that underlie the results reported in publications will be shared, including all collected de-identified IPD.
Data will be available beginning 6 months after publication of the primary results and will remain available for at least 5 years thereafter.
De-identified IPD and supporting documents will be made available upon reasonable request to the Principal Investigator (PI). Requests must include a methodologically sound proposal and intended use. Access will be granted at the discretion of the PI after review of the request.
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| Usual Post-Discharge Care | Combination Product | Usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies. |
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Low-density lipoprotein cholesterol level. Unit of Measure: mmol/L.
| Assessed at 12 months post-discharge |
| LDL-C Goal Attainment | Achieving LDL-C < 1.8 mmol/L. | Assessed at 12 months post-discharge |
| Blood pressure level | Systolic blood pressure and Diastolic blood pressure. Unit of Measure: mmHg. | Assessed at 12 months post-discharge |
| Blood pressure goal attainment | Achieving target BP <130/80 mmHg. | Assessed at 12 months post-discharge |
| Hemoglobin A1c level | Glycated hemoglobin (HbA1c). Unit of Measure: Percentage (%). | Assessed at 12 months post-discharge |
| Smoking | Self-reported current smoking status. Unit of Measure: Number and percentage of current smokers | Assessed at 12 months post-discharge |
| Medication adherence to antiplatelet agents and statins | Adherence is defined as self-reported use of the medication for more than 80% of the time during the past month | Assessed at 12 months post-discharge |
| Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases | Recruiting | Beijing | Beijing Municipality | 100037 | China |
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| Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen | Not yet recruiting | Shenzhen | Guangdong | 518057 | China |
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| The First Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | 050000 | China |
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| The Second Hospital Of Hebe Medical University | Not yet recruiting | Shijiazhuang | Hebei | 050000 | China |
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| The First Affiliated Hospital of Henan University of Science and Technology | Not yet recruiting | Luoyang | Henan | 471003 | China |
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| Henan Provincial Chest Hospital | Not yet recruiting | Zhengzhou | Henan | 450000 | China |
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| Zhengzhou University Affiliated Zhengzhou Central Hospital | Not yet recruiting | Zhengzhou | Henan | 450000 | China |
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| Zhengzhou University Fuwai Central China Cardiovascular Hospital | Not yet recruiting | Zhengzhou | Henan | 450000 | China |
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| The First Affiliated Hospital of Nanjing Medical University | Not yet recruiting | Nanjing | Jiangsu | 210029 | China |
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| Northern Jiangsu People's Hospital | Not yet recruiting | Yangzhou | Jiangsu | 225001 | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | 710004 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | 710061 | China |
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| Shanxi Cardiovascular Disease Hospital | Not yet recruiting | Taiyuan | Shanxi | 030024 | China |
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| The Affiliated Hospital of Southwest Medical University | Not yet recruiting | Luzhou | Sichuan | 400042 | China |
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| The Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | Hangzhou | Zhejiang | 310009 | China |
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