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Wearable ECG for AF Screening and Stroke Risk Assessment
Sponsor: Beijing Tsinghua Chang Gung Hospital
Summary
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.
Official title: Application of Wearable ECG Garments in Atrial Fibrillation Screening and Stroke Risk Assessment
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
OBSERVATIONAL
Enrollment
243
Start Date
2025-04-01
Completion Date
2027-12-31
Last Updated
2025-04-02
Healthy Volunteers
Yes
Conditions
Interventions
Wearable ECG Garment for Continuous Atrial Fibrillation Screening and Stroke Risk Assessment
This 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.
Locations (2)
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Pinggu District Hospital
Beijing, China