Wearable ECG for AF Screening and Stroke Risk Assessment
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorBeijing Tsinghua Chang Gung Hospital
About this trial
This study aims to evaluate the application of wearable ECG garments in atrial fibrillation (AF) screening and stroke risk assessment. Using a prospective, multicenter, observational design, the study will recruit high-risk stroke patients aged 40 and above to undergo 24-hour continuous ECG monitoring with wearable ECG garments. The study will assess the detection rate of AF and explore the correlation between heart rate variability (HRV) parameters and stroke risk. Additionally, the study will analyze the association between P-wave indices and AF, and evaluate the acceptability of the device among patients and healthcare providers. The primary goal is to validate the accuracy of wearable ECG garments in AF detection and explore their predictive value for stroke risk in high-risk populations.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 40 years.
High-risk stroke population identified by the "8+2" risk score in stroke screening.
Ability to operate the device independently or with assistance from family members.
Willingness to participate in the study and provide signed informed consent.
Disqualifiers
Patients with severe diseases that limit device wear (e.g., advanced malignant tumors, severe infections, Class IV heart failure) or those receiving hospice care.
Patients unable to operate the device or understand the study procedures due to cognitive impairment, mental illness, or language communication barriers.
Patients who may experience severe discomfort or allergic reactions from wearing the device.
Patients already using implanted cardiac monitoring devices.
Trial population
The study population consists of individuals aged 40 years and above who are identified as high-risk for stroke based on the "8+2" stroke risk score. This population includes individuals with elevated stroke risk factors such as hypertension, diabetes, smoking history, and family history of stroke. Participants must be able to operate the wearable ECG garment independently or with assistance from family members and must provide informed consent to participate in the study. The study aims to enroll 243 participants to ensure sufficient statistical power for evaluating the accuracy of the wearable ECG garment in detecting atrial fibrillation (AF) and assessing stroke risk.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Wearable ECG Garment for Continuous Atrial Fibrillation Screening and Stroke Risk Assessment
DeviceThis intervention utilizes a wearable ECG garment, a non-invasive, textile-based device for continuous 24-hour ECG monitoring. The garment features embedded electrodes to capture heart rate, rhythm, HRV parameters (e.g., SDNN, RMSSD, LF/HF), and P-wave indices (e.g., P-wave duration, PtfV1), enabling comprehensive assessment of atrial fibrillation (AF) and stroke risk. The device is lightweight, comfortable, and supports wireless data transmission to the cloud for real-time analysis. The study incorporates machine learning algorithms to identify AF patterns and explore stroke risk predictors, targeting individuals aged 40+ at high stroke risk. It also evaluates device acceptability and usability, aiming to improve AF detection rates, enable early intervention, and reduce stroke risk.
Treatment groups
243 Participants
are divided into 1 treatment groupGroup A: High-Risk Stroke Cohort with Wearable ECG Garment1 intervention
Trial outcomes
Primary outcomes
1
Atrial Fibrillation Detection Rate in Stroke High-Risk Populations Using Wearable ECG Garment
1.Atrial Fibrillation (AF) Detection Rate: The proportion of AF cases identified by the wearable ECG garment in the high-risk stroke population during 24-hour continuous monitoring.
Time frame
Baseline to 12 months: Continuous 24-hour ECG monitoring at baseline, with follow-up at 6 and 12 months to assess AF.2
Correlation Between HRV Parameters and Stroke Risk in High-Risk Populations Using Wearable ECG Garment
Correlation Between HRV Parameters and Stroke Risk: Analysis of key HRV parameters (e.g., SDNN, RMSSD, LF/HF) to assess their association with AF and stroke risk in high-risk individuals.
Time frame
Baseline to 12 months: Continuous 24-hour ECG monitoring at baseline, with follow-up at 6 and 12 months to assess stroke.Secondary outcomes
1
Development of an AF Risk Prediction Model Using P-Wave Indices in High-Risk Stroke Populations
Development and validation of an AF risk prediction model incorporating P-wave indices (e.g., P-wave duration, PtfV1) to assess its predictive ability in high-risk stroke populations.
Time frame
P-wave indices collected during 24-hour ECG monitoring at baseline, with model validation using follow-up data at 6 and 12 months.2
Patient and Healthcare Provider Acceptability of Wearable ECG Garment
Evaluation of patient and healthcare provider satisfaction, usability, and comfort with the wearable ECG garment through questionnaires and semi-structured interviews.
Time frame
Baseline to 12 months: Acceptability assessed at baseline (after initial use) and during follow-up visits at 6 and 12 months.3
Incidence of Stroke, AF, and Composite Vascular Events During Long-Term Follow-Up
Occurrence of stroke、AF and Composite vascular events, including myocardial infarction, heart failure, and vascular death during the 12-month follow-up period.
Time frame
Baseline to 12 months: Continuous 24-hour ECG monitoring at baseline, with follow-up assessments at 6 and 12 months to track clinical outcomes.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Tsinghua Chang Gung Hospital
Lead sponsor
Beijing Pinggu District Hospital
Collaborator
Source ClinicalTrials.gov
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