Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease

NCT07031531 | Recruiting DMC

• 1 other identifier: 2023ZD0504005
• Study Type: interventional
• Target: 4,900
• Locations: 1 country
• Sites: 16

Brief Summary

The goal of this clinical trial is to learn if an AI-enabled stratified management system (SMART-CHD) can improve post-discharge outcomes in adults aged 18-45 with premature coronary artery disease. The main questions it aims to answer are:

1. 1.Does SMART-CHD reduce the combined rate of all-cause death, myocardial infarction, stroke and rehospitalization within 12 months?
2. 2.Does SMART-CHD achieve better control of modifiable risk factors compared with usual care?
3. 3.Install and use the SMART-CHD mobile app after a 10-minute structured orientation session with supervised simulations.
4. 4.Complete regular in-app surveys on lifestyle behaviors, laboratory/imaging results and clinical events (with OCR-powered LLM assistance).
5. 5.Wear paired sensors for continuous monitoring of blood pressure, heart rate and other physiologic metrics.
6. 6.Receive automated EHR data harvesting, AI-driven voice-call reminders, and real-time CRC support via a dedicated WeChat group.
7. 7.Follow personalized, guideline-based risk-factor recommendations (diet, exercise, sleep, weight, smoking, alcohol, hypertension, dyslipidemia, diabetes).

Conditions

Premature Coronary Heart Disease

Keywords

Premature coronary heart disease; secondary prevention; long-term management; mobile health; artificial intelligence

Outcome Measures

Primary Outcomes (1)

• Cardiovascular Composite Endpoint Events

  A composite of all-cause death, myocardial infarction, stroke, and unplanned cardiovascular-related rehospitalization.

  Assessed at 12 months post-discharge

Secondary Outcomes (8)

• Individual components of cardiac events

  Assessed at 12 months post-discharge

• LDL-C level

  Assessed at 12 months post-discharge

• LDL-C Goal Attainment

  Assessed at 12 months post-discharge

• Blood pressure level

  Assessed at 12 months post-discharge

• Blood pressure goal attainment

  Assessed at 12 months post-discharge

Study Arms (2)

AI-Enabled Stratified Management Group

EXPERIMENTAL

Participants in the intervention group will use SMART-CHD alongside usual post-discharge care.

Combination Product: AI-Enabled Stratified Management System; Combination Product: Usual Post-Discharge Care

Usual Post-Discharge Care Group

ACTIVE COMPARATOR

Participants in the control group will receive usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies.

Combination Product: Usual Post-Discharge Care

Interventions

AI-Enabled Stratified Management System COMBINATION_PRODUCT

After discharge, participants install SMART-CHD, sync their EHR data, and complete a 10-minute orientation. They then use the app's OCR-assisted surveys to report lifestyle, lab, and event data, while paired wearables stream continuous vitals. AI voice calls and a CRC-managed WeChat group deliver reminders and support. The app's embedded predictive models stratify them into risk tiers and generate tier-specific follow-up schedules. Personalized lifestyle modification guidance, dietary plans, and medication adjustment recommendations are generated by the platform's module. Automated alerts and teleconsultation options are triggered upon detection of high-risk signs or abnormal results, ensuring timely clinical intervention and enhanced secondary prevention.

AI-Enabled Stratified Management Group

Usual Post-Discharge Care COMBINATION_PRODUCT

Usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies.

AI-Enabled Stratified Management Group; Usual Post-Discharge Care Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with coronary heart disease aged 18-45 years;
• The patient or a close family member is capable of using a smartphone and mobile application (App);
• Willing to participate in the study and able to provide written informed consent.

You may not qualify if:

• Severe cognitive impairment;
• Advanced-stage malignancy;
• Life expectancy less than 12 months;
• Severe multi-organ failure;
• Refusal to provide written informed consent.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (16)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230001, China

NOT YET RECRUITING

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

Beijing, Beijing Municipality, 100037, China

RECRUITING

Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen

Shenzhen, Guangdong, 518057, China

NOT YET RECRUITING

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

NOT YET RECRUITING

The Second Hospital Of Hebe Medical University

Shijiazhuang, Hebei, 050000, China

NOT YET RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

NOT YET RECRUITING

Henan Provincial Chest Hospital

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

Zhengzhou University Affiliated Zhengzhou Central Hospital

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

Zhengzhou University Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

NOT YET RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710004, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

NOT YET RECRUITING

Shanxi Cardiovascular Disease Hospital

Taiyuan, Shanxi, 030024, China

NOT YET RECRUITING

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 400042, China

NOT YET RECRUITING

The Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

Central Study Contacts

Gao Prof. Gao, MD, PhD

CONTACT

010-88322413; sophie_gao@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: June 22, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months after publication of the primary results and will remain available for at least 5 years thereafter.
• Access Criteria: De-identified IPD and supporting documents will be made available upon reasonable request to the Principal Investigator (PI). Requests must include a methodologically sound proposal and intended use. Access will be granted at the discretion of the PI after review of the request.

Locations

CN (16)