NCT07908303Not yet recruiting
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning: The WISE Study
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
Stroke is a leading global cause of death and disability. In 2021 there were 11.9 million incident strokes (10.7-13.2 million) and 93.8 million prevalent stroke survivors (89.0-99.3 million) worldwide. The burden in China is particularly severe: stroke is the leading cause of disability-adjusted life years lost, at 45.9 million, and causes more than 2 million deaths each year. Recurrence is common after a first stroke, with reported recurrence rates ranging from 5.7% to 51.3%; approximately 7.7% of patients recur within 3 months and 10.4% within 12 months, and a cohort study of 500,000 Chinese adults found that 41% (95% CI 41%-42%) of stroke survivors had a recurrence at 5 years. Recurrent stroke is associated with higher mortality, greater disability and increased consumption of health care resources, making secondary prevention after stroke the core element of reducing recurrence and improving prognosis. Current stroke prevention and control systems remain largely reactive. Monitoring relies mainly on the patient's subjective perception after symptom onset, emergency response is triggered by telephone calls, and there is no mechanism for pre-symptomatic active sensing or active intervention at onset. The median onset-to-door time in China is still 180-240 minutes and reperfusion treatment rates (2.4%-7%) lag behind those of developed countries. Existing risk assessment tools such as the Framingham score are static models based on demographic characteristics; they cannot reflect the spatiotemporal evolution of physiological parameters in the 24-72 hours before onset and therefore cannot detect a 'recent high-risk state'. Digital health management is mostly one-way information push without bidirectional, agent-driven interaction, resulting in low patient adherence and warning messages that rarely translate into protective action. Wearable health-monitoring devices combined with agentic artificial intelligence offer continuous, real-time and quantifiable physiological monitoring in everyday life. However, the effectiveness, feasibility and safety of such warning and intervention systems for stroke patients, especially for secondary prevention after discharge, have not been systematically evaluated. This study therefore evaluates a stroke early-warning system based on wearable monitoring and clinical data fusion, in order to provide evidence for a digital management model for stroke prevention.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 5000 (estimated)
- First submitted
- 27 Oct 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 1 Oct 2028
- Lead sponsor
- Affiliated Hospital of Nantong University
- Diseases
- Stroke
- NCT number
- NCT07908303
What you commit to
- Study type: Observational
- Planned participants: 5000
- From 1 Oct 2026 to the primary completion date, 1 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Expected survival \< 6 months, or severe cardiac, hepatic, renal or other organ insufficiency or other severe systemic disease that, in the investigator's judgment, makes the participant unsuitable for follow-up.
- Severe cognitive impairment, aphasia, psychiatric illness or disturbance of consciousness that prevents cooperation with the study, where no stable caregiver is available to assist with the study procedures.
- Severe limb dysfunction, or skin allergy or another reason that prevents long-term wearing or normal use of the smart wearable device.
- Current participation in another interventional clinical study that could affect the stroke recurrence outcome.
Who the study is looking for
- Age \>= 18 years.
- Either (a) imaging-confirmed ischemic stroke by cranial CT or MRI within the past 6 months, with at least one of hypertension, diabetes mellitus or atrial fibrillation; OR (b) high risk of stroke, defined as a 10-year stroke risk \>= 7% calculated with the China-PAR (Prediction for ASCVD Risk in China) stroke-specific model. All participants must therefore satisfy the China-PAR study inclusion requirements and provide the data needed for calculation:
- (i) age \>= 35 years; (ii) no known history of cardiovascular disease (for example myocardial infarction, stroke, coronary heart disease); (iii) complete basic health data, including sex, age, current residence (urban/rural), region (north/south, delimited by the Yangtze River), waist circumference, total cholesterol, high-density lipoprotein cholesterol, systolic blood pressure, diastolic blood pressure, use of antihypertensive medication, fasting blood glucose, presence of diabetes mellitus, use of glucose-lowering medication, current smoking status, and family history of stroke.
- Sufficient language and communication ability to understand the study and willingness to sign the informed consent form voluntarily.
- The participant, or the participant's primary caregiver, is able to operate the smart wearable device (smart band and companion mobile application) and is willing to complete the entire follow-up schedule as required by the study.
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.