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.

INTRODUCTION

Effective secondary prevention of coronary heart disease (CHD) is often hindered by limited healthcare resources and poor patient adherence. We therefore developed an artificial intelligence (AI)-enhanced CHD management platform (AIM-CHD) that (i) automatically captures follow-up data through AI-driven voice calls, optical character recognition of laboratory reports and wearable sensor streams; (ii) enables closed-loop, automated risk factor management; and (iii) dynamically personalises follow-up intensity via continuously updated risk stratification and achievement of treatment targets. This trial aims to evaluate whether AIM-CHD improves risk factor control and reduces cardiovascular events compared with usual care.

METHODS AND ANALYSIS

In this prospective, single-centre, open-label, randomised controlled trial, 1100 CHD patients aged 18-85 years will be enrolled at Fuwai Hospital and randomised 1:1 to either the AIM-CHD group (n=550) or the usual care group (n=550) for a 3 month post-discharge intervention. The primary outcome is low-density lipoprotein cholesterol (LDL-C) level at 3 months. Secondary outcomes include target achievement for LDL-C and blood pressure, as well as glycosylated haemoglobin level, nonsmoking status, body mass index, composite cardiovascular endpoint and medication adherence.

ETHICS AND DISSEMINATION

Ethical approval was approved by the Ethics Committee of Fuwai Hospital on 4 November 2024 (2024-2422). The findings will be disseminated in peer-reviewed publications. An anonymised template of the written informed-consent form (Chinese and English versions) is available as Supplementary Material 1.

TRIAL REGISTRATION NUMBER

ClinicalTrial, NCT06686056.