Wearable Devices Assist in the Detection, Screening, and Management of Major Diseases in Middle-aged and Elderly Populations

The goal of this randomized controlled trial is to evaluate the effectiveness of wearable devices (Huawei smartwatches) in aiding the detection, and screening of major diseases (e.g., coronary artery disease, hypertension) in middle-aged and elderly populations aged 40-69 years with cardiovascular risk factors (e.g., smoking, diabetes, hypertension, dyslipidemia). The main questions it aims to answer are: Does AI-assisted diagnosis using wearable device data improve the detection rate of coronary artery stenosis (CAD-RADS ≥3) compared to standard physician assessment without AI assistance? Does the intervention reduce the incidence of coronary artery disease-related events (e.g., angina, myocardial infarction) within one year? Researchers will compare the intervention group (AI model-assisted diagnosis based on Huawei smartwatch data) with the control group (standard assessment) to determine if the AI-aided smartwatch approach enhances diagnostic accuracy and clinical outcomes. Participants will: （Intervention group）Wear a Huawei smartwatch for 24 hours to collect physiological data (e.g., PPG signals, heart rate, motion). Undergo baseline assessments, including medical history review, physical exams, and laboratory tests. Receive a preliminary diagnosis from a general practitioner. Complete a follow-up evaluation after one year to track cardiovascular events and other disease outcomes. Undergo coronary CTA if suspected of coronary stenosis.

NCT Number	NCT06980064
Lead Sponsor	Tongji Hospital Collaborators: Geriatric Hospital of Nanjing Medical University, Yangzhou University, Shanghai Health and Medical Center, Weifang Hospital of Traditional Chinese Medicine, CR & WSICO general hospital, Xunxian People's Hospital
Conditions	Coronary Stenosis, Cerebral Arterial Diseases, Hypertension, Parkinson Disease, Heart Failure, Peripheral Arterial Occlusive Disease, Thyroid Dysfunction
Enrollment	800 participants
Start Date	2025-06-01
Primary Completion	2025-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-20