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The goal of this clinical trial is to find out if an artificial intelligence (AI)-enhanced mobile app can help people with coronary heart disease (CHD) better manage their health after being discharged from the hospital. The main questions it aims to answer are:
Researchers will compare the AI-enhanced app to usual care, where participants receive usual health advice without using the app.
Participants will:
The study hopes to show that using an AI-enhanced app can make it easier for people with CHD to stay healthy and avoid future heart problems.
The AIM-CHD app was developed by a diverse team at Fuwai Hospital, including doctors, nurses, patients, and software engineers. It gathers information from synchronized hospital records, questionnaires, intelligent voice follow-ups, and wearable devices. Using this data, it categorizes patients by risk level, detects unmanaged risk factors, and generates individualized follow-up schedules and intervention plans. When risk factors are not well controlled, the app alerts patients to these issues. It also reminds users to monitor their health markers regularly, follow prescribed medication routines, and offers personalized health education focused on lifestyle adjustments. The app can assess the severity of blood pressure, heart rate, blood glucose, and lipid levels, advising patients to seek in-person consultations if necessary. AIM-CHD also recognizes emergency scenarios and provides options for online consultations or immediate help from Fuwai Hospital to prevent treatment delays. The platform leverages artificial intelligence (AI) for efficient lab report image recognition and speech-to-text conversion, streamlining follow-up care. Additionally, it offers customized patient education. The AIM-CHD's intervention goals and strategies are grounded in the latest clinical guidelines. The system is built with a front-end and back-end separation architecture: the back-end is developed with the .NET framework using C#, while the front-end is a WeChat mini-program created with JavaScript and React.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIM-CHD Mobile Health Intervention Group | Experimental | Participants in the intervention group will be trained to use the AIM-CHD for post-discharge care,while also receiving post-discharge usual care. |
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| Standard Post-Discharge Care Group | Active Comparator | Participants in the control group will receive usual post-discharge care, which includes oral and written instructions on sustained pharmacotherapy regimens, recommended follow-up frequency, and lifestyle modifications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIM-CHD Mobile Health Intervention | Combination Product | The AIM-CHD platform synchronizes data from hospitalization records, questionnaires, AI-powered voice follow-ups, and wearable devices to perform risk stratification and manage uncontrolled risk factors. It provides individualized follow-up plans, medication reminders, and lifestyle education, with real-time assessments of vital health metrics to prompt necessary in-person consultations. The app offers online consultation access and emergency services through Fuwai Hospital. Additionally, it delivers personalized patient education, aligning with the latest clinical guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C levels | LDL-C levels (mmol/L) | measured at 3 months post-discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C Target Attainment Rate | Proportion of patients achieving LDL-C <1.8 mmol/L | assessed at 3 months post-discharge |
| Blood Pressure Control Rate | Proportion of patients with controlled blood pressure, defined as systolic pressure <130 mmHg and diastolic pressure <80 mmHg. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases | Beijing | Beijing Municipality | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40953879 | Derived | Ba Z, Zhao S, Liu M, Chen G, Lian X, Yu F, Su Y, Wang Z, Yang L, Wang X, Zhang X, Yuan J, Gao X, Zhao W, Wu Y. Effectiveness of an AI-enhanced management system for coronary heart disease (AIM-CHD): rationale and design of a single-centre, open-label, randomised, parallel-controlled trial. BMJ Open. 2025 Sep 14;15(9):e105597. doi: 10.1136/bmjopen-2025-105597. |
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The individual participant data collected in this study contains sensitive information. Although de-identified, the data will not be publicly shared to protect participant privacy and in accordance with the requirements of the ethics committee.
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| Usual post-discharge care | Combination Product | Usual post-discharge care includes oral and written instructions on sustained pharmacotherapy regimens, recommended follow-up frequency, and lifestyle modifications. |
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| assessed at 3 months post-discharge |
| Glycosylated Hemoglobin Levels | assessed at 3 months post-discharge |
| Smoking Rate | Proportion of patients who are still smoking | assessed at 3 months post-discharge |
| BMI | body mass index | assessed at 3 months post-discharge |
| Cardiovascular Composite Endpoint Events | Incidence of all-cause mortality, non-fatal myocardial infarction, stroke, and rehospitalization. | assessed at 3 months post-discharge |
| Medication Adherence | Proportion of patients adhering to antiplatelet agents and statins, defined as taking medications for more than 80% of the prescribed time over the past month. | assessed at 3 months post-discharge |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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