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Recruiting NCT07031531

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

No phase Interventional Premature Coronary Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-Enabled Stratified Management System, Usual Post-Discharge Care.
Who it may be relevant to
Registry conditions: Premature Coronary Heart Disease. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease (SMART-CHD): A Prospective, Multicenter, Open-Label, Randomized Controlled Trial

Overview

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

Interventions

  • Combination product AI-Enabled Stratified Management System
    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
  • Combination product Usual Post-Discharge Care
    Usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies.

Primary outcome measures

  • Cardiovascular Composite Endpoint Events [Time frame: Assessed at 12 months post-discharge]
Secondary outcome measures (8)
  • Individual components of cardiac events [Time frame: Assessed at 12 months post-discharge]
  • LDL-C level [Time frame: Assessed at 12 months post-discharge]
  • LDL-C Goal Attainment [Time frame: Assessed at 12 months post-discharge]
  • Blood pressure level [Time frame: Assessed at 12 months post-discharge]
  • Blood pressure goal attainment [Time frame: Assessed at 12 months post-discharge]
  • Hemoglobin A1c level [Time frame: Assessed at 12 months post-discharge]
  • Smoking [Time frame: Assessed at 12 months post-discharge]
  • Medication adherence to antiplatelet agents and statins [Time frame: Assessed at 12 months post-discharge]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 16 centers
  • The First Affiliated Hospital of University of Science and Technology of China — Hefei
  • Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Dis — Beijing
  • Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen — Shenzhen
  • The First Hospital of Hebei Medical University — Shijiazhuang
  • The Second Hospital Of Hebe Medical University — Shijiazhuang
  • The First Affiliated Hospital of Henan University of Science and Technology — Luoyang
  • Henan Provincial Chest Hospital — Zhengzhou
  • Zhengzhou University Affiliated Zhengzhou Central Hospital — Zhengzhou
  • … and 8 more centers

Identifiers

NCT: NCT07031531 · 2023ZD0504005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗