Status:
NOT_YET_RECRUITING
Wearable Devices Assist in the Detection, Screening, and Management of Major Diseases in Middle-aged and Elderly Populations
Lead Sponsor:
Tongji Hospital
Collaborating Sponsors:
Geriatric Hospital of Nanjing Medical University
The Affiliated Hospital of Yangzhou University
Conditions:
Coronary Stenosis
Cerebral Arterial Diseases
Eligibility:
All Genders
40-69 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06980064
Start Date
June 1 2025
End Date
December 31 2026
Last Update
May 20 2025
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