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NCT Number: NCT06980064

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

The exclusion criteria:

  • 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.

Treatment and study plan

Smartwatch + GP

Diagnostic Test

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.

GP only

Diagnostic Test

GPs will make diagnosis with clinical interviews and aforementioned baseline examination results to formulate a final diagnosis.

Primary outcomes

  1. Coronary heart disease

    Time frame: 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 outcomes

  1. Major adverse cardiovascular events

    Time frame: 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 outcomes

  1. Detection rate of other major chronic diseases

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Yucong Zhang, PhD

CONTACT

[email protected]

86 13627115411

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

  • CR & WSICO general hospital
  • Geriatric Hospital of Nanjing Medical University
  • Shanghai Health and Medical Center
  • Weifang Hospital of Traditional Chinese Medicine
  • Xunxian People's Hospital
  • Yangzhou University

Registry information

Official study title

Wearable Devices Assist in the Detection, Screening, and Management of Major Diseases in Middle-aged and Elderly Populations: a Multicenter Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 20, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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