PROgnostic Value of MicroParticles and Markers of Hemostasis in TIA and Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- Fatal or non-fatal ischemic stroke or myocardial infarction.
研究概览
简要总结
The purpose is to investigate if different microparticles and markers of hemostasis predict outcome after TIA or ischemic stroke and to study the association between these variables and stroke subtype or etiology.
详细描述
- Introduction Within a previous study ('PROPPSTOPP') a cohort of 249 patients with ischemic stroke (IS) or TIA was established in Stockholm between 2007 and 2009. The original aims were twofold: 1) to look for occult atrial fibrillation (completed, NTC01160406) and 2) to investigate microparticle levels and markers of hemostasis in the acute phase and one month after symptoms. Blood samples were taken on both occasions. Patients were found to have higher microparticle levels and increased thrombin generation in plasma both acutely and at one month as compared to healthy controls.
This follow-up study will investigate the prognostic ability of microparticles (primary variables) and markers of hemostasis (secondary variables) to predict outcome as documented in hospital records and Swedish registers. The association between microparticles/coagulation markers and stroke subtype/etiology will also be investigated. 2. Variables
2.1 Microparticles
Microparticles are membrane vesicles (0.1-1.0 µm) released from cells at activation or apoptosis. They carry surface markers from the releasing cell. Microparticles are of interest as biomarkers for activation of cells in the circulation, e g platelets, endothelial cells or leukocytes. They may have pro-coagulant properties. For this study the following microparticles and surface markers have been analyzed:
- Total number of microparticles (MP's)
- Number of MP's exposing phosphatidylserine (PS) (pro-coagulant property)
- Number of MP's of any type exposing tissue factor (TF), with or without simultaneous exposure of PS (pro-coagulant properties, activation of monocytes/endothelium)
- Number of platelet microparticles (PMP's), identified by surface exposure of GPαIIb (CD41), with or without simultaneous exposure of PS (platelet activation)
- Number of PMP's exposing P-selectin with or without simultaneous exposure of PS (platelet activation)
- Number of PMP's exposing TF with or without simultaneous exposure of PS (pro-coagulant properties)
2.2 Markers of hemostasis
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •acute ischemic stroke or TIA less than 2 weeks before enrollment
- •ability to understand study instructions both verbal and written
- •ability to handle handheld ECG
排除标准
- •known atrial fibrillation
- •hemorrhagic stroke at time of enrollment
- •limited compliance
- •pacemaker
结局指标
主要结局
Fatal or non-fatal ischemic stroke or myocardial infarction.
时间窗: 2007-2014
New fatal or non-fatal ischemic stroke after the initial ischemic stroke or TIA leading to recruitment. Outcome events and time of events are extracted from national registries ('Patientregistret', 'Dödsorsaksregistret') and hospital records.
次要结局
- Recurrent ischemic stroke(2007-2014)
- All-cause mortality(2007-2014)
研究者
Ann Charlotte Laska
Associate professor
Karolinska Institutet