[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585814":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":31,"locations":36,"responsibleParty":61,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":10,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":10,"enrollmentInfo":76,"targetDuration":79,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":91,"whyStopped":10,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Beijing Tsinghua Chang Gung Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"High-Risk Stroke Cohort with Wearable ECG Garment",null,"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\u002FHF), 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.",[13],"Device: Wearable ECG Garment for Continuous Atrial Fibrillation Screening and Stroke Risk Assessment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","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\u002FHF), 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.",[9],[21,25,28],{"name":22,"affiliation":23,"role":24},"Jian Wu, MD.","BeijingTsinghua Changgung Hospital, School of Clinical Medicine,Tsinghua Medicine, Tsinghua University","STUDY_CHAIR",{"name":26,"affiliation":23,"role":27},"Yating Wu, MD.","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":30,"role":27},"Yifei Chen, MD.","Pinggu District Hospital",[32],{"name":26,"role":33,"phone":34,"phoneExt":10,"email":35},"CONTACT","+86 56119526","wuyating926@163.com",[37,52],{"facility":38,"status":10,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Beijing Tsinghua Changgung Hospital","Beijing","Beijing Municipality","102218","China","CN",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},[51],{"name":26,"role":33,"phone":34,"phoneExt":10,"email":35},{"facility":30,"status":10,"city":39,"state":10,"zip":53,"country":42,"countryCode":43,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"101200",{"type":45,"coordinates":55},[47,48],{"lat":48,"lon":47},[58],{"name":29,"role":33,"phone":59,"phoneExt":10,"email":60},"13264334052","13264334052@wo.cn",{"type":62,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[64],{"name":65,"class":6},"Beijing Pinggu District Hospital","100585814","wearable-ecg-for-af-screening-and-stroke-risk-assessment-100585814",false,"NCT06907264","Wearable ECG for AF Screening and Stroke Risk Assessment","Application of Wearable ECG Garments in Atrial Fibrillation Screening and Stroke Risk Assessment","Inclusion Criteria:\n\n1. Age ≥ 40 years.\n2. High-risk stroke population identified by the \"8+2\" risk score in stroke screening.\n3. Ability to operate the device independently or with assistance from family members.\n4. Willingness to participate in the study and provide signed informed consent.\n\nExclusion Criteria:\n\n1. Patients with severe diseases that limit device wear (e.g., advanced malignant tumors, severe infections, Class IV heart failure) or those receiving hospice care.\n2. Patients unable to operate the device or understand the study procedures due to cognitive impairment, mental illness, or language communication barriers.\n3. Patients who may experience severe discomfort or allergic reactions from wearing the device.\n4. Patients already using implanted cardiac monitoring devices.",true,"ALL","40 Years",{"count":77,"type":78},243,"ESTIMATED","12 Months","OBSERVATIONAL","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.",[83,84],"Atrial Fibrillation","Stroke",[86,87,84,88,89,90],"Wearable ECG garment","Atrial fibrillation","Heart rate variability","Observational study","High-risk stroke population","NOT_YET_RECRUITING","2025-03-26",{"date":94,"type":95},"2025-04-02","ACTUAL",{"date":97,"type":78},"2025-04-01",{"date":99,"type":78},"2027-12-31",{"name":5,"class":6},2]