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

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

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.

Study Overview

• Status: Completed
• Conditions: Secondary Prevention of Coronary Heart Disease
• Intervention / Treatment: Combination product: AIM-CHD Mobile Health Intervention; Combination product: Usual post-discharge care

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.

• Study Type: Interventional
• Enrollment (Actual): 1100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100037
      • Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AIM-CHD Mobile Health Intervention Group; Participants in the intervention group will be trained to use the AIM-CHD for post-discharge care，while also receiving post-discharge usual care.	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.
Active Comparator: Standard Post-Discharge Care Group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-C levels	LDL-C levels (mmol/L)	measured at 3 months post-discharge.

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: mobile health; Coronary heart disease; artificial intelligence; secondary prevention
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2024-GSP-GG-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No