Mobile Phones in Cryptogenic Stroke Patients Bringing Single Lead ECGs to Detect Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 57
- 试验地点
- 13
- 主要终点
- Percentage of detected atrial fibrillation
研究概览
简要总结
The main objective of this study is to compare the incidence of detected atrial fibrillation (AF) in cryptogenic stroke patients by a single lead ECG device with the incidence of detected AF by a 7-Day Holter ECG.
详细描述
Rationale: A standard work-up of stroke patients to identify a cause of stroke consists of Computed Tomography (CT), CT angiography of head and neck arteries, transthoracic echocardiography, 12-lead 10-seconds electrocardiogram (ECG), blood tests and 24-hour ECG monitoring. A stroke is called "cryptogenic" if no cause can be determined after standard work-up. Current detection of atrial fibrillation (AF) after stroke is 2.0%. Recent studies revealed that prolonged monitoring yields higher percentages of detected AF (12.0%). Devices used in these trials suffer from drawbacks. The investigators' hypothesis is that a new, smartphone compatible device, producing a single lead ECG (single lead ECG device), can be used for prolonged ECG monitoring in cryptogenic stroke patients.
Objective: The main objective of this study is to compare the incidence of detected AF in cryptogenic stroke patients by a single lead ECG device with the incidence of detected AF by a 7-Day Holter ECG.
Study design: A multicenter randomized trial. Study population: Cryptogenic stroke patients admitted to a hospital participating in the study. The calculated sample size is 200 (100 per arm).
Intervention: After inclusion, patients will be randomized to either a single lead ECG device or a 7-Day Holter Monitor.
Main study parameters/endpoints: The main endpoint will be the percentage of detected atrial fibrillation in both the single lead ECG device group and the 7-Day Holter group after one year.
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
- None
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
- •Patients must have had an episode of symptomatic Transient ischemic attack (TIA) or episode of ischemic stroke.
- •Ischemic stroke is defined as an episode of transient or neurological dysfunction caused by focal brain or retinal ischemia with recent infarction on imaging
- •A TIA is defined as transient episode of neurologic dysfunction typically lasting less than one hour caused by focal brain or retinal ischemia without recent infarction on imaging.
排除标准
- •Known etiology of TIA or ischemic stroke
- •TIA or stroke caused by spinal ischemia
- •TIA only presenting with non-localising symptoms
- •Uncertainty about the diagnosis of TIA because of unclear clinical symptoms
- •Myocardial infarction <6 months before stroke
- •Coronary Artery Bypass Grafting <6 months before stroke
- •Severe valvular heart disease
- •Documented history of atrial fibrillation or atrial flutter
- •Permanent indication for oral anticoagulation at enrolment
- •Patient has permanent OAC contraindication
- •Patient is included in another randomized trial
- •Left ventricular aneurysm on echocardiography
- •Thrombus on echocardiographyRenal dysfunction (creatinine clearance <30 mL/min/1.73m2)
- •Patient has life expectancy of <1 year
- •Patient is not willing to sign the informed consent form
- •Patient is <18 years of age
- •Patient is considered an incapacitated adult
- •Patient is not in possession of a smartphone with Android Operating System (OS) or iOS.
结局指标
主要结局
Percentage of detected atrial fibrillation
时间窗: 1 year of follow-up
次要结局
- Number of participants with a recurrent stroke or TIA as defined in the trial(Within one year after cryptogenic stroke)
- Pro-Brain Natriuretic Peptide (Pro-BNP) levels in pg/mL(24 hours after cryptogenic stroke)
- Left atrial diameter in cm/m2(24 hours after cryptogenic stroke)
- Number of participants with a major bleeding(Within one year after cryptogenic stroke)
- Percentages of atrial ectopy detected on 7-Day Holter monitor(7 days after cryptogenic stroke)
- Left atrial volume in mL/m2(24 hours after cryptogenic stroke)
研究者
Serge A. Trines
S.A.I.P. Trines, Senior Cardiologist
Leiden University Medical Center