Stroke of Unknown Cause: The Impact of Long-term Heart Monitoring on Stroke Recurrence in Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Atrial fibrillation deteceted after stroke and transient ischemic attack (TIA)
研究概览
简要总结
The goal of this observational study is to investigate sex - differences in detection rate of atrial fibrillation after cryptogenic stroke (embolic stroke of unknown cause) - using an implantable cardiac rhythm monitor - and the treatment effects of oral anticoagulation on recurrent stroke, ischemic cardiovascular events, major bleeding risk, disability and mortality.
The main questions to answer are:
- Is long-term monitoring and detection of atrial fibrillation after stroke of unknown cause in women related to recurrent stroke and disability?
- Is long-term monitoring and initiation of oral anticoagulation related to cardiovascular events and intracranial haemorrhages? And in addition increased in women compared to men?
- Is long-term rhythm monitoring after stroke with unknown cause related to patient reported outcomes in women?
详细描述
This is a prospective, observational, study including consecutive patiens with acute cryptogenic stroke /embolic stroke of unknown source (ESUS) or transient ischemic attack (TIA) admitted between 2016 and 2023 at Akershus University Hospital (AUH). As part of the standard investigation at AUH, selected patients are offered an implantable cardiac monitor (ICM) and followed up for detection of atrial fibrillation (AF) by a specialised neurocardiology team. A control group recruited at another hospital during the same period, Haukeland University Hospital (HUS), only comprise women.
The primary objectives:
- To investigate among women with stroke of unknown cause, the effect of implantable cardiac monitors compared to standard non-invasive approach on AF detection, recurrent stroke, death and disability.
- To investigate sex- differences in patients with stroke of unknown cause, the effect of implantable cardiac monitors on AF detection, recurrent stroke, death and disability.
Secondary objectives:
- To compare the rate of cardiovascular events and intracranial haemorrhages after stroke of unknown cause in women offered implantable cardiac monitors, compared to best standard non-invasive follow up
- To investigate the impact of implantable cardiac monitors on the use of oral anticoagulation in women
- To investigate self-perceived health and health related quality of life after stroke of unknown cause in women offered implantable loop recorders, compared to women offered best standard non-invasive approach to detect AF
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with cryptogenic stroke or TIA, according to the TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification and an implantable cardiac rythm monitor (ICM) for the ICM group not the control
排除标准
- •Patients with known or newly detected AF on standard ECG or 24 h Holter ECG.
- •Patients on oral anticoagulants (OAC) for non-AF indications
- •Patients with strong contraindications for OAC
- •Severe cognitive impairment or disability or with a short life expectancy due to comorbidities of less than two years.
结局指标
主要结局
Atrial fibrillation deteceted after stroke and transient ischemic attack (TIA)
时间窗: 30 days and 1 year after index stroke
\>30 seconds of atrial fibrillation detection using implantable cardiac monitor/implantable loop-recorder
Recurrent ischemic stroke after 1 and 2 years
时间窗: 30 days, 1 and 2 years after index stroke
Ischemic stroke/TIA: Clinical diagnosis (TOAST criteria) verified by CT and/or MR.
次要结局
- Composite of stroke and mortality(30 days, 1 and 2 years after index stroke)
- Ischemic cardiac events(1 and 2 years)
- Intracranial bleeding(30 days, 1 and 2 years after index stroke)
- Patient Reported Outcome Measureres(3 months after index stroke)
- Safety outcome(1 and 2 years after index stroke)
- Oral anticoagulation(1 and 2 years)
- Functional outcome 3 months post-stroke(3 months after index stroke)
研究者
Jannicke Koldaus-Falch
Neurologist and PhD- candidate
University Hospital, Akershus