Clinical trial NCT06980064: Wearable Devices Assist in the Detection, Screening, and Management of Major Diseases in Middle-aged and Elderly Populations
Official title: Wearable Devices Assist in the Detection, Screening, and Management of Major Diseases in Middle-aged and Elderly Populations: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Stenosis
Cerebral Arterial Diseases
Hypertension
Parkinson Disease
Heart Failure
Peripheral Arterial Occlusive Disease
Thyroid Dysfunction
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Geriatric Hospital of Nanjing Medical University
name: The Affiliated Hospital of Yangzhou University
name: Shanghai Health and Medical Center
name: Weifang Hospital of Traditional Chinese Medicine
name: CR & WSICO general hospital
name: Xunxian People's Hospital
First posted: 2025-05-20
Enrollment: 800
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility 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.

Primary outcomes:
measure: Coronary heart disease
timeFrame: From enrollment to the diagnosis, generally within 1 week
Secondary outcomes:
measure: Major adverse cardiovascular events
timeFrame: From enrollment to 1 year of follow-up
Other outcomes:
measure: Detection rate of other major chronic diseases
timeFrame: From enrollment to the diagnosis, generally within 1 week
Locations:
Study officials:
affiliation: Wuhan TongJi Hospital
name: Cuntai Zhang, PhD
role: STUDY_CHAIR
References: