Artificial Intelligence-Enhanced Management for Coronary Heart Disease (AIM-CHD) : Impact on Cholesterol and Other CHD Risk Factors

National Center for Cardiovascular Diseases

Status: Completed

Conditions: Secondary Prevention of Coronary Heart Disease

Treatments: Combination Product: AIM-CHD Mobile Health Intervention; Combination Product: Usual post-discharge care

Study type: Interventional

Funder types: Other

Identifiers

NCT06686056

2024-GSP-GG-4

Details and patient eligibility

About

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:

1. Does the AI-enhanced app help lower bad cholesterol (LDL-C) levels within 3 months after leaving the hospital?
2. Does the app improve other health measures, like blood pressure, blood sugar control, weight, medication adherence and cardiac events?

Researchers will compare the AI-enhanced app to usual care, where participants receive usual health advice without using the app.

Participants will:

1. Be randomly assigned to use either the AI-enhanced app or receive usual care.
2. Use the app to track and manage their health, receive reminders, and get educational tips.
3. Attend checkups at 3 months to measure cholesterol levels and other health outcomes.

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.

Full description

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.

Enrollment: 1,100 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CHD patients aged 18-85 years
• ability of the patient or close relatives to use smartphones and applications
• willingness to participate and sign the informed consent form

Exclusion criteria

• severe cognitive impairment
• advanced malignant tumors
• expected survival of less than 3 months
• severe multi-organ failure
• refusal to sign the informed consent form

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,100 participants in 2 patient groups

AIM-CHD Mobile Health Intervention Group

Experimental group

Description:

Participants in the intervention group will be trained to use the AIM-CHD for post-discharge care，while also receiving post-discharge usual care.

Treatment:

Combination Product: Usual post-discharge care

Combination Product: AIM-CHD Mobile Health Intervention

Standard Post-Discharge Care Group

Active Comparator group

Description:

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.

Treatment:

Combination Product: Usual post-discharge care