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

Официальное название

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

Обзор

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).

Вмешательства

• Комбинированный продукт 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
• Комбинированный продукт Usual Post-Discharge Care
  Usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies.

Первичные конечные точки

• Cardiovascular Composite Endpoint Events [Срок оценки: Assessed at 12 months post-discharge]

Вторичные конечные точки (8)

• Individual components of cardiac events [Срок оценки: Assessed at 12 months post-discharge]
• LDL-C level [Срок оценки: Assessed at 12 months post-discharge]
• LDL-C Goal Attainment [Срок оценки: Assessed at 12 months post-discharge]
• Blood pressure level [Срок оценки: Assessed at 12 months post-discharge]
• Blood pressure goal attainment [Срок оценки: Assessed at 12 months post-discharge]
• Hemoglobin A1c level [Срок оценки: Assessed at 12 months post-discharge]
• Smoking [Срок оценки: Assessed at 12 months post-discharge]
• Medication adherence to antiplatelet agents and statins [Срок оценки: Assessed at 12 months post-discharge]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 16 центров

• The First Affiliated Hospital of University of Science and Technology of China — Хэфэй
• Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Dis — Пекин
• Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen — Шэньчжэнь
• 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 — Чжэнчжоу
• Zhengzhou University Affiliated Zhengzhou Central Hospital — Чжэнчжоу
• … и ещё 8 центров

Идентификаторы

NCT: NCT07031531 · 2023ZD0504005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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