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

Abstract

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.

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