Prospective Study Evaluating the Interest of Long-term Cardiac Recording in Cerebral Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Cardiac monitoring
研究概览
简要总结
Cerebral infarction (CI) can be linked to atherosclerosis of large vessels, occlusion of small vessels intracerebral (gaps), a cardioembolic disease or other rare causes. However, up to 40% of CI remains unexplained after a thorough diagnostic workup. They are called cryptogenic IC.
Atrial fibrillation (AF) is the cause of 25% of the CI but it is recognized that episodes of paroxysmal AF, asymptomatic and unnoticed, may be responsible for a portion of the IC cryptogenic pace. Recognition of these episodes is of great importance since they have the same risk embolic the FA continues [1, 2] and motivate anticoagulant therapy startup.
Several recording techniques heart rate were evaluated after the IC for detecting the AF. Their profitability increases with the duration of the recording: about 3% for a typical 24-hour Holter, the AF detection rate increases to 6% for a 7-day surveillance period, to 12-23% for 30 days and 17-26% with implantable recorders long.
Otherwise brief rhythmic heart abnormalities can be detected with the waning of an CI without the significance of these episodes is known.
Investigators decided to conduct this study because there is no prospective study of good quality with a sufficient number of patients that evaluated the interest of a non-invasive recording of long duration. The only randomized CRYSTAL AF is used for invasive subcutaneous implantable monitor (Reveal XT).
To clarify the significance of arrhythmias and because the presence of several causes is common after 65, investigators propose to record all patients hospitalized for HF.
详细描述
Main objective / secondary The objectives of our study were to assess the prevalence of AF in patients hospitalized for an IC and to detect and describe all heart rhythmic abnormalities reported immediately to the waning of an IC cryptogenic (ie without cause or without obvious cause ) for non-invasive cardiac monitoring.
- The primary endpoint: number of patients in whom it was found AF
- Secondary Endpoints: typical patient subgroups in which it was discovered AF and other rhythm abnormalities; Description of the population under prescribed anticoagulation following SpiderFlash® recordings, cardiac ultrasound parameters (including the surface of the left atrium and the index of the function of the mitral annulus) and rhythmic anomalies in groups with atheromatous and cryptogenic stroke.
Inclusion / non inclusion Inclusion criteria
- Patients over 65 years, hospitalized for cerebral infarction ICU Neurovascular
- No history of atrial fibrillation or flutter
- No hypercoagulable
- Patient unopposed and capable of carrying 21-day monitoring Exclusion criteria
- Patients with severe cognitive impairment that can not keep SpiderFlash® for 21 days
- Previous history of AF or flutter
- Significant artery stenosis requiring specific treatment (endarterectomy or stenting)
- FA on arrival at the ICU Neurovascular
- Trucks of a pacemaker or cardiac defibrillator
- Deadline for the IC more than 10 days
- Other sources of cardiac embolism
- Pejorative prognosis (mRS≥5)
The IC is defined as a central focal neurological deficit of sudden onset and is confirmed by a CT scan or MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU Neurovascular hospitalized for cerebral infarction CI
- •No history of atrial fibrillation or flutter
- •No hypercoagulable
- •Patient unopposed and capable of carrying 21-day monitoring
排除标准
- •Patients with severe cognitive impairment that can not keep SpiderFlash® for 21 days
- •Previous history of AF or flutter
- •Significant artery stenosis requiring specific treatment (endarterectomy or stenting)
- •FA on arrival at the ICU Neurovascular
- •Trucks of a pacemaker or cardiac defibrillator
- •Deadline for the CI more than 10 days
- •Other sources of cardiac embolism
- •Pejorative prognosis (mRS≥5)
研究组 & 干预措施
Uses of SpiderFlash monitor
The intervention corresponds to the use of Spiderflash as Holter monitor. Investigators will use the SpiderFlash®, Holter monitor (technology "Secure Data") to have a storage capacity enabling a registration up to 30 days with sufficient autonomy.
A questionnaire evaluating the safety of SpiderFlash® will be given to the patient and the results of Holter will be communicated at the end of the recording to the blinded rhythm specialist.
干预措施: Uses of SpiderFlash monitor (Device)
结局指标
主要结局
Cardiac monitoring
时间窗: During the 30 days of monitoring
Data concerning cardiac monitoring: time, duration, number of detected events
次要结局
- NIHSS score(Day 1)
- Treatment influencing the rate(During the 30 days of monitoring)