Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients - REMOTE Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 225
- 试验地点
- 4
- 主要终点
- AF detection with mHealth versus ILR - Percentage
研究概览
简要总结
The purpose of this study is to demonstrate the added value of mobile health (mHealth) to detect atrial fibrillation (AF) early in the care path of cryptogenic stroke and transient ischemic attack (TIA) patients.
详细描述
The use of photoplethysmography (PPG)-based mHealth (with smartphone and smartwatch) is compared to the guideline-recommended insertable loop recorders (ILR) in the detection of AF in cryptogenic stroke or TIA patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
盲法说明
The participant and care provider are not blinded for which mHealth method is used (smartphone or smartwatch), but are blinded for the mHealth results (i.e., AF detection) during the monitoring period with the mHealth application.
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
- •Diagnosis of cryptogenic ischemic stroke or TIA
- •The patient or its legal representative is willing to sign the informed consent
排除标准
- •History of AF or atrial flutter
- •Life expectancy of less than one year
- •Not qualified for ILR insertion
- •Indication or contraindication for permanent oral anticoagulants (OAC) at enrolment
- •Untreated hyperthyroidism
- •Myocardial infarction or coronary bypass grafting less than one month before the stroke onset
- •Presence of patent foramen ovale (PFO) and it is or was an indication to start OAC according to the European Stroke Organization guidelines
- •Inclusion in another clinical trial that will affect the objectives of this study
- •Not able to understand the Dutch language
- •Patient or partner not in possession of a smartphone
结局指标
主要结局
AF detection with mHealth versus ILR - Percentage
时间窗: After 6 months of having an ILR inserted and using mHealth.
Percentage of patients with AF detected
次要结局
- AF detection with ILR - Percentage(After 12 months of having an ILR inserted.)
- AF detection with mHealth versus ILR - Time to first AF detection(Baseline until end of study (after 12 months of having an ILR inserted).)
- AF detection with mHealth versus ILR - Frequency(Baseline until end of study (after 12 months of having an ILR inserted).)
- AF detection with mHealth versus ILR - Duration(Baseline until end of study (after 12 months of having an ILR inserted).)
- User experience and feeling of safety questionnaire(After 6 months of having an ILR inserted and using mHealth.)
- Correlation between baseline characteristics and AF detection(Baseline until end of study (after 12 months of having an ILR inserted).)
- Correlation between follow-up characteristics and AF detection(Baseline until end of study (after 12 months of having an ILR inserted).)
研究者
David Verhaert, MD
Dr.
Ziekenhuis Oost-Limburg