Application of Wearable ECG Garments in Atrial Fibrillation Screening and Stroke Risk Assessment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 243
- 试验地点
- 2
- 主要终点
- Atrial Fibrillation Detection Rate in Stroke High-Risk Populations Using Wearable ECG Garment
研究概览
简要总结
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.
详细描述
This study is a prospective, multicenter, observational study designed to evaluate the application of wearable ECG garments in atrial fibrillation (AF) screening and stroke risk assessment. The study will be conducted at two centers: the Tsinghua Community under the jurisdiction of Tsinghua University Hospital and the Pinggu District under the jurisdiction of Pinggu District Hospital. The study design includes the following key components:
Study Population:
The study population consists of individuals aged 40 and above who are at high risk of stroke, as determined by the "8+2" stroke risk score.
Participants must be able to operate the wearable ECG garment independently or with the assistance of family members and must provide informed consent.
Sample Size:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Atrial Fibrillation Detection Rate in Stroke High-Risk Populations Using Wearable ECG Garment
时间窗: Baseline to 12 months: Continuous 24-hour ECG monitoring at baseline, with follow-up at 6 and 12 months to assess AF.
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.
Correlation Between HRV Parameters and Stroke Risk in High-Risk Populations Using Wearable ECG Garment
时间窗: Baseline to 12 months: Continuous 24-hour ECG monitoring at baseline, with follow-up at 6 and 12 months to assess stroke.
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.
次要结局
- 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.)