Wearable ECG for AF Screening and Stroke Risk Assessment

Launched by BEIJING TSINGHUA CHANG GUNG HOSPITAL · Mar 26, 2025

Keywords

ClinConnect Summary

This clinical trial is looking into how wearable ECG (electrocardiogram) garments can help identify atrial fibrillation (AF), a heart condition, and assess the risk of stroke in patients who are at higher risk. The study will include individuals aged 40 and older who have been identified as high-risk for stroke. Participants will wear these devices for 24 hours to continuously monitor their heart activity. The researchers want to see how well these garments can detect AF and understand how different heart rate patterns relate to stroke risk. They also aim to find out if patients and healthcare providers find these wearable devices easy and acceptable to use.

To be eligible for this study, participants must be at least 40 years old and classified as high-risk for stroke according to a specific scoring system. They should be able to wear and operate the device on their own or with help from family and be willing to provide consent to join the study. However, those with serious health conditions that could prevent them from wearing the device, or who already have other heart monitoring devices, won't be able to participate. If you choose to join, you can expect to wear the ECG garment for a full day while going about your normal activities, and your heart’s activity will be closely monitored to help improve understanding of AF and stroke risk.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 40 years.
• • 2. High-risk stroke population identified by the "8+2" risk score in stroke screening.
• • 3. Ability to operate the device independently or with assistance from family members.
• • 4. Willingness to participate in the study and provide signed informed consent.
• Exclusion Criteria:
• • 1. Patients with severe diseases that limit device wear (e.g., advanced malignant tumors, severe infections, Class IV heart failure) or those receiving hospice care.
• • 2. Patients unable to operate the device or understand the study procedures due to cognitive impairment, mental illness, or language communication barriers.
• • 3. Patients who may experience severe discomfort or allergic reactions from wearing the device.
• • 4. Patients already using implanted cardiac monitoring devices.