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.
Aged more than equal to 40 years, less than 69 years.
Agree to receive coronary CTA if suspected to have coronary artery stenosis.
Voluntarily joined and signed the informed consent.
Previously diagnosed with CAD or considered moderate to severe coronary stenosis (CAD-RADS grade 3 or above: stenosis degree of 50% or above) through coronary CTA or coronary angiography examination.
Pregnant women or women planning to become pregnant within the next year.
During the onset of the disease and needs in-hospital treatment.
Tattoos or other substances that affect optical signals on the wrist.
Parallel
Smartwatch + GP
Diagnostic testParticipants in the intervention group will be required to wear a smartwatch continuously for 24 hours. After this period, the collected data will be processed using a pre-trained foundational model for disease diagnosis, generating preliminary diagnostic suggestions. GPs will then integrate these smartwatch-derived findings with clinical interviews and aforementioned baseline examination results to formulate a final diagnosis.
GP only
Diagnostic testGPs will make diagnosis with clinical interviews and aforementioned baseline examination results to formulate a final diagnosis.
Coronary heart disease
According to the results of coronary computed tomography angiography , coronary heart disease is diagnosed if the stenosis of the coronary artery exceeds 50% (CAD-RADS grade 3 and above).
Major adverse cardiovascular events
Major adverse cardiovascular events, including myocardial infarction, stroke, aortic dissection, cardiac arrest and death from baseline to 1 year of follow-up
Detection rate of other major chronic diseases
All relevant diseases will be diagnosed according to relevant guidelines, including cerebral vascular stenosis (cerebral artery computed tomography angiography), hypertension (blood pressure measurement), nocturnal hypertension (blood pressure measurement), heart failure (echocardiogram), cardiomyopathy (echocardiogram), peripheral arterial disease (vascular ultrasonography), thyroid dysfunction (thyroid function test), systemic lupus erythematosus (symptom and laboratory tests), Parkinson's disease (symptom) and sleep apnea syndrome (polysomnography).
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Tongji Hospital
Lead sponsor
Geriatric Hospital of Nanjing Medical University
Collaborator
Yangzhou University
Collaborator
Shanghai Health and Medical Center
Collaborator
Weifang Hospital of Traditional Chinese Medicine
Collaborator
CR & WSICO general hospital
Collaborator
Xunxian People's Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
