Wearable Devices Assist in the Detection, Screening, and Management of Major Diseases in Middle-aged and Elderly Populations: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 800
- 主要终点
- Coronary heart disease
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria are as follows:
- •Aged more than equal to 40 years, less than 69 years.
- •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)
- •Agree to receive coronary CTA if suspected to have coronary artery stenosis.
- •Voluntarily joined and signed the informed consent.
排除标准
- •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.
- •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.
- •Physical disability, blindness, and deafness.
- •Allergic history of contrast agent containing iodine.
研究组 & 干预措施
Intervention group (AI smartwatch assisted diagnosis)
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. General pratitioners will then integrate these smartwatch-derived findings with clinical interviews and aforementioned baseline examination results to formulate a final diagnosis.
干预措施: Smartwatch + GP (Diagnostic Test)
Control group (general pratitioner only)
Participants in the control group will not wear smart watches. General pratitioners will base their diagnoses solely on clinical interviews and the aforementioned baseline examinations.
干预措施: GP only (Diagnostic Test)
结局指标
主要结局
Coronary heart disease
时间窗: 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).
次要结局
- Major adverse cardiovascular events(From enrollment to 1 year of follow-up)