Observational Study on Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- First AF episode detected by the implantable loop recorder in patients that had a cryptogenic stroke. An AF episode will be considered an AF episode that lasts at least 2 minutes.
研究概览
简要总结
STUDY TYPE:
Prospective, national , multicenter, and observational study.
OBJECTIVE:
To assess the incidence of AF in patients with cryptogenic stroke who have implanted an AF detection device during a period of 2 years.
DEVICE:
Reveal XT 9529 (SQDM)
SAMPLE SIZE AND STUDY DURATION:
100 patients enrolled which will be followed during a period of 2 years.
详细描述
Observational study in patients with cryptogenic stroke (TOAST criteria) and with an implanted EKG loop recorder, with the primary objective of knowing the atrial fibrillation incidence in this population
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients included must meet one of these two conditions:
- •Patient presenting with an episode of transient ischemic attack (TIA) of cryptogenic origin with neurological symptoms of less than 24h of evolution and negative neuroimaging.
- •First episode of ischaemic stroke with cryptogenic etiology following TOAST criteria
- •All patients must meet all of the following:
- •The patient has been implanted an ILR within 30 days after qualifying event
- •Age between 45-85 years
- •No stenosis >50% in any arterial vessel corresponding to the affected territory
- •Normal Echocardiography
- •Normal 24 hours EKG Holter recording
- •Absence of Patent Foramen Ovale through transcranial doppler (or transesophageal echocardiography)
- •Acceptance and signature of Patient Informed Consent.
排除标准
- •All patients included cannot meet any of the following conditions:
- •Recurrent stroke or TIA
- •Stroke or TIA with determined etiology according to TOAST criteria.
- •Anticoagulation indication at the time of enrollment in the study.
- •Total contraindication for anticoagulation therapy
- •Atrial fibrillation detection prior to enrollment
- •Severe cognitive impairment or dementia
- •Patient unable to be followed up
- •Patients enrolled in another clinical trial
- •Patients with life expectancy of less than 1 year
- •Pregnancy
结局指标
主要结局
First AF episode detected by the implantable loop recorder in patients that had a cryptogenic stroke. An AF episode will be considered an AF episode that lasts at least 2 minutes.
时间窗: Patients will be followed up during two years, regardless of reaching or not the primary endpoint.
次要结局
- All subsequent AF episodes detected by the ILR after primary outcome (AF burden)(Patients will be followed up during two years)
- AF episodes detected by external monitoring(Patients will be followed up during two years)
- Presence of stroke, recurrent TIA, or silent infarction in neuroimaging(Patients will be followed up during two years)
- Changes in anticoagulant therapy(Patients will be followed up during two years)