Coronary StenosisNCT06980064
Wearable Devices Assist in the Detection, Screening, and Management of Major Diseases in Middle-aged and Elderly Populations
A study testing Smartwatch + GP and GP only in people with Coronary Stenosis and Cerebral Arterial Diseases, run by Tongji Hospital.
Trial 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.… Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- Coronary Stenosis, Cerebral Arterial Diseases, Hypertension
- What is being tested?
- Smartwatch + GP and GP only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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?
Read more
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.
- Conditions
- Coronary Stenosis, Cerebral Arterial Diseases, Hypertension, Parkinson Disease, Heart Failure, Peripheral Arterial Occlusive Disease
- Being tested
- Smartwatch + GP, GP only
- Medical subject headings
- Coronary Stenosis, Cerebral Arterial Diseases, Hypertension, Parkinson Disease, Heart Failure, Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartwatch + GPDiagnostic 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 onlyDiagnostic test
GPs will make diagnosis with clinical interviews and aforementioned baseline examination results to formulate a final diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (AI smartwatch assisted diagnosis) | Experimental | 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. Receives: Diagnostic Test: Smartwatch + GP |
| Control group (general pratitioner only) | Active comparator | 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. Receives: Diagnostic Test: GP only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the diagnosis, generally within 1 week
Secondary outcomes (1)
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
Measured: From enrollment to 1 year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Geriatric Hospital of Nanjing Medical University, Yangzhou University, Shanghai Health and Medical Center, Weifang Hospital of Traditional Chinese Medicine, CR & WSICO general hospital, Xunxian People's Hospital
- Responsible party
- Principal investigator, Zhang Cuntai, Tongji Hospital
- Investigators
- Cuntai Zhang, PhD, Study chair, Wuhan TongJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980064
- Sponsor's protocol ID
- 2024S212
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to data policy of Huawei and Tongji hospital, individual level data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06980064
- Acronym / sponsor ID
- 2024S212
- Conditions
- Coronary Stenosis, Cerebral Arterial Diseases, Hypertension, Parkinson Disease, Heart Failure, Peripheral Arterial Occlusive Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Geriatric Hospital of Nanjing Medical University, Yangzhou University, Shanghai Health and Medical Center, Weifang Hospital of Traditional Chinese Medicine, CR & WSICO general hospital, Xunxian People's Hospital
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (AI smartwatch assisted diagnosis) | Experimental | Diagnostic Test: Smartwatch + GPParticipants 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. |
| Control group (general pratitioner only) | Active comparator | Diagnostic Test: GP onlyParticipants in the control group will not wear smart watches. General pratitioners will base their diagnoses solely on clinical interviews and the aforementioned baseline examinations. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartwatch + GPParticipants 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 test | Intervention group (AI smartwatch assisted diagnosis) |
| GP onlyGPs will make diagnosis with clinical interviews and aforementioned baseline examination results to formulate a final diagnosis. | Diagnostic test | Control group (general pratitioner only) |
Primary outcome
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).
1 secondary outcome
Major adverse cardiovascular events
Time frame: From enrollment to 1 year of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No. According to data policy of Huawei and Tongji hospital, individual level data will not be shared.
Related trials for Coronary Stenosis
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cuntai Zhang, PhD study chair
Wuhan TongJi Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Smartwatch + GP and GP only in people with Coronary Stenosis and Cerebral Arterial Diseases, run by Tongji Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yucong Zhang, PhD (86 13627115411, u201110541@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary heart disease (time frame: From enrollment to the diagnosis, generally within 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.