NCT06686056

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

A Single-Center, Open-Label, Randomized, Parallel Controlled Trial Evaluating the Effectiveness of Artificial Intelligence-Enhanced Management for Coronary Heart Disease (AIM-CHD) Delivered Via Mobile Application

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,100 (actual)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Secondary Prevention of Coronary Heart Disease

Interventions

Type	Name	Description
COMBINATION_PRODUCT	AIM-CHD Mobile Health Intervention	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.
COMBINATION_PRODUCT	Usual post-discharge care	Usual post-discharge care includes oral and written instructions on sustained pharmacotherapy regimens, recommended follow-up frequency, and lifestyle modifications.

Timeline

• Start date: 2024-11-23
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2024-11-13
• Last updated: 2025-09-19

Locations

1 site across 1 country: China