Cerebral Arterial Diseases, Coronary Stenosis, Heart Failure, Hypertension, Parkinson Disease, Peripheral Arterial Occlusive Disease, Thyroid Dysfunction
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTSmartwatch + GP
Participants 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.
DIAGNOSTIC_TESTGP only
GPs will make diagnosis with clinical interviews and aforementioned baseline examination results to formulate a final diagnosis.
Sponsors
Geriatric Hospital of Nanjing Medical University
The Affiliated Hospital of Yangzhou University
Shanghai Health and Medical Center
Weifang Hospital of Traditional Chinese Medicine
CR & WSICO general hospital
Xunxian People's Hospital
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
The inclusion criteria are as follows: 1. Aged more than equal to 40 years, less than 69 years. 2. Having at least one of the following conditions (with one risk factor for cardiovascular and cerebrovascular diseases): ① Male ≥ 55 years old, female ≥ 65 years old; ② Smokers or those who quit smoking within the past 3 months prior to the visit; ③ Diabetes (type 1 or 2); ④ Hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg) or currently taking antihypertensive medication; ⑤ Dyslipidemia: total cholesterol ≥ 5.18mmol/L, triglycerides ≥ 1.70mmol/L, high-density lipoprotein\<1.04mmol or low-density lipoprotein ≥ 3.37mmol/L; ⑥ hsCRP\>3.0 mg/L; ⑦ 10-year ASCVD risk of 20% or more (calculated according to the formula designed in the PREVENT study) 3. Agree to receive coronary CTA if suspected to have coronary artery stenosis. 4. Voluntarily joined and signed the informed consent. The
Exclusion criteria
1. 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. 2. Pregnant women or women planning to become pregnant within the next year. 3. During the onset of the disease and needs in-hospital treatment. 4. Tattoos or other substances that affect optical signals on the wrist. 5. Severe arrhythmia patients, including third degree atrioventricular block, ventricular escape rhythm, severe sinus bradycardia, sick sinus syndrome, supraventricular tachycardia, ventricular tachycardia, atrial fibrillation, atrial flutter, ventricular fibrillation, ventricular flutter. 6. Physical disability, blindness, and deafness. 7. Allergic history of contrast agent containing iodine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coronary heart disease | From enrollment to the diagnosis, generally within 1 week | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular events | From enrollment to 1 year of follow-up | Major adverse cardiovascular events, including myocardial infarction, stroke, aortic dissection, cardiac arrest and death from baseline to 1 year of follow-up |
Other
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of other major chronic diseases | From enrollment to the diagnosis, generally within 1 week | 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). |
Contacts
Primary ContactYucong Zhang, PhD
Outcome results
None listed