Clinical trial NCT06686056: Artificial Intelligence-Enhanced Management for Coronary Heart Disease (AIM-CHD) : Impact on Cholesterol and Other CHD Risk Factors
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Secondary Prevention of Coronary Heart Disease
Keywords: Coronary heart disease
secondary prevention
mobile health
artificial intelligence
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2024-11-13
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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.

Eligibility criteria: 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

Primary outcomes:
measure: LDL-C levels
timeFrame: measured at 3 months post-discharge.
Secondary outcomes:
measure: LDL-C Target Attainment Rate
timeFrame: assessed at 3 months post-discharge
measure: Blood Pressure Control Rate
timeFrame: assessed at 3 months post-discharge
measure: Glycosylated Hemoglobin Levels
timeFrame: assessed at 3 months post-discharge
measure: Smoking Rate
timeFrame: assessed at 3 months post-discharge
measure: BMI
timeFrame: assessed at 3 months post-discharge
measure: Cardiovascular Composite Endpoint Events
timeFrame: assessed at 3 months post-discharge
measure: Medication Adherence
timeFrame: assessed at 3 months post-discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases
state: Beijing
Study officials:
References: