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临床试验/NCT01423201
NCT01423201已完成不适用

TIA Triage Trial and Evaluation of Vascular-Specific Inflammatory BiomarkerLp-PLA2 as a Stratification Tool for TIA Triage and Stroke Risk

Stanford University3 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
262
试验地点
3
主要终点
vascular events

研究概览

简要总结

Transient ischemic attack (TIA) is a transient neurological deficit (speech disturbance, weakness...), caused by temporary occlusion of a brain vessel by a blood clot that leaves no lasting effect.

TIA diagnosis can be challenging and an expert stroke evaluation combined with magnetic resonance imaging (MRI) could improve the diagnosis accuracy.

The risk of a debilitating stroke can be as high as 5% during the first 72 hrs after TIA.

TIA characteristics (duration, type of symptoms, age of the patient), the presence of a significant narrowing of the neck vessels responsible for the patient's symptoms (symptomatic stenosis), and an abnormal MRI are associated with an increased risk of stroke.

An emergent evaluation and treatment of TIA patients by a stroke specialist could reduce the risk of stroke to 2%.

Stanford has implemented an expedited triage pathway for TIA patients combining a clinical evaluation by a stroke neurologist, an acute MRI of the brain and the vessels and a sampling of biomarkers (Lp-PLA2). The investigators are investigating the yield of this unique approach to improve TIA diagnosis, prognosis and secondary stroke prevention. The objective of this prospective cohort study is to determine which factors will help the physician to confirm the diagnosis of TIA and to define the risk of stroke after a TIA.

详细描述

Patients with a clinical suspicion of TIA seen at the Stanford Emergency Department, will be admitted to the Clinical Decision Area (CDA). The CDA is a short duration (<24 hrs)) hospitalization unit, where the patient can receive expedited evaluation and monitoring in a more comfortable setting than in the ED. Patients will be evaluated by a neurologist (resident with fellow or stroke attending). Clinical information will be collected in a dedicated chart.

Evaluation:

As recommended by the AHA, in the absence of contraindications, all the patients will undergo an MRI of the brain and a neck vessel evaluation as part of standard care. This exam will be obtained within 6 hours after patient admission to the emergency department. The diffusion sequence of the brain MRI will detect the presence of an acute injury related to a blood clot (ischemic injury), and the perfusion sequence will capture abnormal intra-cerebral blood flow. The other sequences will exclude the presence of other brain lesions susceptible to explain the transient symptoms presented by the patient. The MR angiogram (MRA) of the neck and intracranial vessels will detect the presence of a symptomatic stenosis that would require emergent treatment. In case of MRI contraindication, the patient will undergo a CT of the head and neck combining neck and intracranial vessel evaluation and perfusion imaging.

As recommended, patients will get an EKG and a cardiovascular examination as part of routine care.

As recommended, patients will get a standard lab evaluation as part of routine care including general chemistry, hematology, coagulation, lipid profile, Hb A1C), and if indicated, a specific prothrombotic and an inflammatory evaluation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Men and Women age greater than 18 year old
  • Symptoms suggestive of an acute TIA

排除标准

  • Patients with contraindication to brain imaging: MRI and CT.
  • Patient with persistent major deficit (NIHSS> or = 4)
  • Informed consent could not be obtained either directly from the patient or from legally authorized representative.
  • Severe coexisting or terminal systemic disease with like expectancy below 90 days or that may interfere with the conduct of the study.

结局指标

主要结局

vascular events

时间窗: 90 days

次要结局

  • Vascular Events(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gregory W Albers

MD, Professor of Neurology

Stanford University

研究点 (3)

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