Chest Strap and PPG-device Compared to Holter-device for Atrial Fibrillation Detection: 24 Hour Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Chest strap data quality
研究概览
简要总结
Aims Approximately 20-25% of strokes are of cardioembolic origin, atrial fibrillation (AF) being a significant cause of cardioembolic strokes. AF is often symptomless and intermittent, making its detection a clinical challenge. Currently the golden standard for diagnosis of AF is by 12-lead electrocardiogram (ECG) or any other ECG-strip.
The primary aim of the study is to assess the potential of chest strap as an ECG monitor especially in arrhythmia detection by cardiologist and algorithm. The secondary aim is to assess potential of photoplethysmography (PPG) based device for arrhythmia detection.
详细描述
Study design:
Study design will be a prospective case-control study at Kuopio University Hospital (KUH) in Finland. Study material will be collected in internal medicine emergency department at KUH. The study design was approved by University of Eastern Finland ethics committee (347/2018).
Study participants will receive a written information sheet about the study and will be provided with an opportunity to ask questions concerning the study. A written informed consent will be signed by the participants, including a permission to use patient's medical records.
Screening of study participants will be made in participating hospitals from admitted patients in January 2018 - May 2019. The inclusion criteria for study group patients was atrial fibrillation confirmed by a doctor-interpreted 12-lead ECG . Exclusion criteria were: body mass index (BMI) over 35; implanted pacemaker device; 12-lead ECG findings of left bundle branch block (LBBB) or right bundle branch block (RBBB); medical condition requiring immediate treatment that would be delayed by the study measurements; serious infectious disease. Control group consisted of patients with normal sinus rhythm (SR) in 12-lead ECG.
Measurement
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atrial fibrillation in 12-lead ECG and admission to hospital (n=50) Sinus rhythm in 12-lead ECG and admission to hospital (n=50)
排除标准
- •medical condition requiring immediate treatment
- •serious infectious disease
结局指标
主要结局
Chest strap data quality
时间窗: 24 hours
Is chest strap ECG non-inferior or superior for the atrial fibrillation detection as compared to Holter recording. Measures for determining outcome; sensitivity and specificity for the atrial fibrillation detection.
次要结局
- Data quality to enable arrhythmia diagnosis(24 hours)
研究者
Tero Martikainen
Chief physician
Kuopio University Hospital