Wearable ECG for AF Screening and Stroke Risk Assessment

NCT06907264 | Not Yet Recruiting DMC

• 1 other identifier: 2023YFC2506600
• Study Type: observational
• Target: 243
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Atrial Fibrillation; Stroke

Keywords

Wearable ECG garment; Atrial fibrillation; Stroke; Heart rate variability; Observational study; High-risk stroke population

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to 12 months: Continuous 24-hour ECG monitoring at baseline, with follow-up at 6 and 12 months to assess AF.

• 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.

  Baseline to 12 months: Continuous 24-hour ECG monitoring at baseline, with follow-up at 6 and 12 months to assess stroke.

Secondary Outcomes (3)

• Development of an AF Risk Prediction Model Using P-Wave Indices in High-Risk Stroke Populations

  P-wave indices collected during 24-hour ECG monitoring at baseline, with model validation using follow-up data at 6 and 12 months.

• Patient and Healthcare Provider Acceptability of Wearable ECG Garment

  Baseline to 12 months: Acceptability assessed at baseline (after initial use) and during follow-up visits at 6 and 12 months.

• Incidence of Stroke, AF, and Composite Vascular Events During Long-Term Follow-Up

  Baseline to 12 months: Continuous 24-hour ECG monitoring at baseline, with follow-up assessments at 6 and 12 months to track clinical outcomes.

Study Arms (1)

High-Risk Stroke Cohort with Wearable ECG Garment

This cohort consists of individuals aged 40 and above who are at high risk of stroke, as determined by the "8+2" stroke risk score. Participants will wear a wearable ECG garment for 24-hour continuous ECG monitoring to detect atrial fibrillation (AF) and assess stroke risk. The device will record heart rate, rhythm, HRV parameters (e.g., SDNN, RMSSD, LF/HF), and P-wave indices. The study aims to evaluate the accuracy of the wearable ECG garment in AF detection, explore the correlation between HRV parameters and stroke risk, and assess the acceptability of the device among patients and healthcare providers. Participants will undergo follow-up at 6 and 12 months to monitor the occurrence of stroke, AF, and other cardiovascular events.

Device: Wearable ECG Garment for Continuous Atrial Fibrillation Screening and Stroke Risk Assessment

Interventions

Wearable ECG Garment for Continuous Atrial Fibrillation Screening and Stroke Risk Assessment DEVICE

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.

High-Risk Stroke Cohort with Wearable ECG Garment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead
• Beijing Pinggu District Hospital: collaborator

Study Sites (2)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

Location

Pinggu District Hospital

Beijing, 101200, China

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Jian Wu, MD.

  BeijingTsinghua Changgung Hospital, School of Clinical Medicine,Tsinghua Medicine, Tsinghua University

  STUDY CHAIR

• Yating Wu, MD.

  BeijingTsinghua Changgung Hospital, School of Clinical Medicine,Tsinghua Medicine, Tsinghua University

  PRINCIPAL INVESTIGATOR

• Yifei Chen, MD.

  Pinggu District Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yating Wu, MD.

CONTACT

+86 56119526; wuyating926@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)