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Completed

NCT Number: NCT06686056

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

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.

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Key information

Conditions

Secondary Prevention of Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. LDL-C levels

    Time frame: measured at 3 months post-discharge.

    LDL-C levels (mmol/L)

Secondary outcomes

  1. LDL-C Target Attainment Rate

    Time frame: assessed at 3 months post-discharge

    Proportion of patients achieving LDL-C <1.8 mmol/L

  2. Blood Pressure Control Rate

    Time frame: assessed at 3 months post-discharge

    Proportion of patients with controlled blood pressure, defined as systolic pressure <130 mmHg and diastolic pressure <80 mmHg.

  3. Glycosylated Hemoglobin Levels

    Time frame: assessed at 3 months post-discharge

  4. Smoking Rate

    Time frame: assessed at 3 months post-discharge

    Proportion of patients who are still smoking

  5. BMI

    Time frame: assessed at 3 months post-discharge

    body mass index

  6. Cardiovascular Composite Endpoint Events

    Time frame: assessed at 3 months post-discharge

    Incidence of all-cause mortality, non-fatal myocardial infarction, stroke, and rehospitalization.

  7. Medication Adherence

    Time frame: assessed at 3 months post-discharge

    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.

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

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

Acronym: AIM-CHD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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