Yield of Implantable Cardiac Monitoring Device in Patients With Acute Ischemic Stroke.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Paroxysmal Atrial Fibrillation > 120 seconds
研究概览
简要总结
In this prospective cohort study, the investigators aim to investigate the incidence of ICM-detected AF in unselected ischemic stroke patients and its association with anticoagulation initiation and stroke recurrence.
详细描述
The study will be conducted among 4 tertiary centers of the cardioneurology network in the Athens Metropolitan area ("Attikon" University Hospital, Hippokrateion Hospital, "Georgios Gennimatas" General Hospital of Athens, NIMITS General Hospital of Athens). The Second Department of Neurology of the National and Kapodistrian University of Athens in "Attikon" University Hospital would also act as the coordinating center, comprising of a research group with significant clinical experience and numerous publications on PCM and stroke.
Consecutive acute ischemic stroke or TIA patients aged 40 years or older will be enrolled. Diagnosis of acute ischemic stroke will be based on clinical and neuroimaging evaluation [brain computed tomography (CT) scan or magnetic resonance imaging (MRI) scan]. Classification of stroke will be defined using the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria. Patients with incomplete evaluation will be excluded, as previously described. Patients with known or newly detected AF at hospitalization will also be excluded. Stroke patients of all other etiologies presenting a HAVOC score ≥4 will be included in the study. Informed consent for participation in the study will be obtained from the patients or guardians of patients.
Sample size
Similar to previous studies, approximately 200 eligible patients will be recruited during a 4-year period (50 patients/year). Based on a retrospective analysis of the local stroke registry and considering the eligibility criteria for this study, it is estimated that at least 1,000 stroke patients should be screened in order to enroll 200 participants.
Baseline Evaluation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive acute ischemic stroke or TIA patients aged 40 years or older will be enrolled.
- •Diagnosis of acute ischemic stroke will be based on clinical and neuroimaging evaluation [brain computed tomography (CT) scan or magnetic resonance imaging (MRI) scan].
- •Stroke patients of all other etiologies (apart AF) presenting a HAVOC score ≥4 will be included in the study.
- •Informed consent for participation in the study will be obtained from the patients or guardians of patients.
排除标准
- •Patients with incomplete evaluation will be excluded, as previously described. [22] -Patients with known or newly detected AF at hospitalization will also be excluded.
- •Not providing informed consent.
结局指标
主要结局
Paroxysmal Atrial Fibrillation > 120 seconds
时间窗: 3 years
the incidence of paroxysmal AF lasting 120 seconds or more in included patients evaluated with ICM.
次要结局
- stroke subtypes(3 years)
- major hemorrhagic events(3 years)
- anticoagulant initiation(3 years)
- comparison versus historical cohort(3 years)
- Paroxysmal Atrial Fibrillation > 6 minutes(3 years)
- biomarkers(3 years)
- recurrent ischemic strokes(3 years)
- subclinical infracts on follow-up MRI(3 years)
研究者
Georgios Tsivgoulis
Professor & Chairman of Second Department of Neurology, School of Medicine, National & Kapodistrian University of Athens, "Attikon" University Hospital, Athens, Greece
National and Kapodistrian University of Athens