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
Qualifiers
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 design
Treatments tested in this trial
- Wearable ECG Garment for Continuous Atrial Fibrillation Screening and Stroke Risk Assessment
Treatment groups
243 Participants
are divided into 1 treatment groupSponsors and collaborators
Beijing Tsinghua Chang Gung Hospital
Lead sponsor
Beijing Pinggu District Hospital
Collaborator
Source ClinicalTrials.gov