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
1 other identifier
interventional
1,100
1 country
1
Brief 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?
- 3.Be randomly assigned to use either the AI-enhanced app or receive usual care.
- 4.Use the app to track and manage their health, receive reminders, and get educational tips.
- 5.Attend checkups at 3 months to measure cholesterol levels and other health outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2024
CompletedFirst Posted
Study publicly available on registry
November 13, 2024
CompletedStudy Start
First participant enrolled
November 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedSeptember 19, 2025
September 1, 2025
7 months
November 11, 2024
September 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LDL-C levels
LDL-C levels (mmol/L)
measured at 3 months post-discharge.
Secondary Outcomes (7)
LDL-C Target Attainment Rate
assessed at 3 months post-discharge
Blood Pressure Control Rate
assessed at 3 months post-discharge
Glycosylated Hemoglobin Levels
assessed at 3 months post-discharge
Smoking Rate
assessed at 3 months post-discharge
BMI
assessed at 3 months post-discharge
- +2 more secondary outcomes
Study Arms (2)
AIM-CHD Mobile Health Intervention Group
EXPERIMENTALParticipants in the intervention group will be trained to use the AIM-CHD for post-discharge care，while also receiving post-discharge usual care.
Standard Post-Discharge Care Group
ACTIVE 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.
Interventions
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 includes oral and written instructions on sustained pharmacotherapy regimens, recommended follow-up frequency, and lifestyle modifications.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- severe cognitive impairment
- advanced malignant tumors
- expected survival of less than 3 months
- severe multi-organ failure
- refusal to sign the informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037, China
Related Publications (1)
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.
PMID: 40953879DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2024
First Posted
November 13, 2024
Study Start
November 23, 2024
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
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.