AzTrials
AzTrials

Secondary Prevention of Coronary Heart DiseaseAIM-CHDNCT06686056

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

A study testing AIM-CHD Mobile Health Intervention and Usual post-discharge care in people with Secondary Prevention of Coronary Heart Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
AIM-CHD Mobile Health Intervention and Usual post-discharge care
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,100 participants
Where
1 siteChina
Study dates
23 Nov 2024to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

China1 site

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

    Beijing, Beijing Municipality, 100037

Other trials in China

About this study

Official 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

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?
Read more

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.

Read the 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.

Being tested
AIM-CHD Mobile Health Intervention, Usual post-discharge care
Keywords
Coronary heart disease, secondary prevention, mobile health, artificial intelligence
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AIM-CHD Mobile Health InterventionCombination 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 careCombination product

    Usual post-discharge care includes oral and written instructions on sustained pharmacotherapy regimens, recommended follow-up frequency, and lifestyle modifications.

Study groups in NCT06686056
Study groupRoleWhat they receive
AIM-CHD Mobile Health Intervention GroupExperimentalParticipants in the intervention group will be trained to use the AIM-CHD for post-discharge care，while also receiving post-discharge usual care.
Receives: Combination Product: AIM-CHD Mobile Health Intervention; Combination Product: Usual post-discharge care
Standard Post-Discharge Care GroupActive comparatorParticipants 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.
Receives: Combination Product: Usual post-discharge care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LDL-C levels

    LDL-C levels (mmol/L)

    Measured: measured at 3 months post-discharge.

Secondary outcomes (7)

  1. LDL-C Target Attainment Rate

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

    Measured: assessed at 3 months post-discharge

  2. Blood Pressure Control Rate

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

    Measured: assessed at 3 months post-discharge

  3. Glycosylated Hemoglobin Levels

    Measured: assessed at 3 months post-discharge

  4. Smoking Rate

    Proportion of patients who are still smoking

    Measured: assessed at 3 months post-discharge

  5. BMI

    body mass index

    Measured: assessed at 3 months post-discharge

  6. Cardiovascular Composite Endpoint Events

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

    Measured: assessed at 3 months post-discharge

  7. 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.

    Measured: assessed at 3 months post-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2024
  2. Study start23 Nov 2024
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06686056
Sponsor's protocol ID
2024-GSP-GG-4
Acronym
AIM-CHD
Status last verified
Sep 2025
First submitted
11 Nov 2024
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Ba Z, Yuan J, Zhao S, Liu M, Chen G, Lian X, Yu F, Su Y, Wang Z, Yang L, Wang X, Wang Y, Zhang X, Zhao W, Gao X, Wu Y. Artificial intelligence-enhanced management system for secondary prevention of coronary heart disease: a randomized clinical trial. BMC Med. 2026 Aug 18;24(1):449. doi: 10.1186/s12916-026-05135-w.

    PubMed 42613609

  • 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.

    PubMed 40953879

Questions about this trial

What is this clinical trial studying?

A study testing AIM-CHD Mobile Health Intervention and Usual post-discharge care in people with Secondary Prevention of Coronary Heart Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LDL-C levels (time frame: measured at 3 months post-discharge.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06686056, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in