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临床试验/NCT02450721
NCT02450721Unknown不适用

Clinical and Laboratory Biomarkers in Patients With Atherothrombotic Stroke

St. Petersburg State Pavlov Medical University1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
97
试验地点
1
主要终点
Mean concentration of Pregnancy-associated Plasma Protein A (PAPP A)

研究概览

简要总结

Aim of the present study is to investigate molecular and clinical markers in patients with atherosclerotic carotid stenosis (ACAS) in the ischemic stroke acute phase.

详细描述

Background: Laboratory biomarkers of atherosclerosis can be valuable in decision about operative treatment in patients with mild to severe atherosclerotic carotid stenosis (ACAS) and high stroke risk. However nowadays there are no established instruments for personalized atherothrombotic stroke diagnostics. Aim of the present study was to access atherosclerosis biomarkers serum levels in patients with ACAS during the ischemic stroke/ transient ischemic attack (TIA) acute phase.

Main objective of the study To explore informative biomarkers to determine the risk of stroke in patients with significant ACAS.

Secondary objectives

  1. To investigate the association between the degree of neurological and cognitive deficits , the features of the disease , the severity of brain lesions according to neuroimaging data with the concentration of lipoprotein -associated phospholipase A2 (LP-PL-A2), high sensitive C- reactive protein (hsCRP) , pregnancy-associated plasma protein A (PAPP-A), asymmetric dimethylarginine (ADMA), lipoprotein (a) in patients with atherothrombotic stroke.
  2. To find the most valuable laboratory biomarkers of atherosclerosis , to compare them with clinical and objective data to make decision about inclusion of these biomarkers in routine practice as a screening test of atherosclerotic plaque instability and for stroke risk prediction and in decision about operative treatment in patients with ACAS.

Design and Methods A single-blind cross-sectional trial was performed to investigate laboratory biomarkers of atherosclerosis in patients with atherosclerotic stenosis of the internal carotid artery 50-99 % , and in healthy volunteers. Randomizing and blinding technique: laboratory scientist and statistician do not have information about the belonging of biomaterials patient to any of the groups studied .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 50-99% atherosclerotic carotid artery stenosis
  • Acute atherothrombotic stroke/TIA (according to TOAST-criteria) within the first 3 days after vascular event

排除标准

  • risk factors of non-atherothrombotic stroke (according to TOAST-criteria)
  • exacerbation of decompensated chronic diseases
  • infections
  • acute cardiovascular diseases
  • large operation during 1 month before enrollment
  • Cortexin, Actovegin, Cerebrolysin, Erythropoetin administration during 1 week before enrollment.
  • Stable ACAS
  • Inclusion Criteria:
  • 50-99% atherosclerotic carotid artery stenosis
  • no history of vascular events during one month before enrollment
  • Exclusion Criteria:
  • risk factors of non-atherothrombotic stroke (according to TOAST-criteria)
  • exacerbation of decompensated chronic diseases
  • infections
  • acute cardiovascular diseases
  • large operation during 1 month before enrollment
  • Cortexin, Actovegin, Cerebrolysin, Erythropoetin administration during 1 week before enrollment.
  • Control group
  • Inclusion Criteria:
  • intima media thickness less then 1mm
  • no history of stroke/TIAs
  • Exclusion Criteria:
  • risk factors of non-atherothrombotic stroke (according to TOAST-criteria)
  • exacerbation of decompensated chronic diseases
  • infections
  • acute cardiovascular diseases
  • large operation during 1 month before enrollment
  • Cortexin, Actovegin, Cerebrolysin, Erythropoetin administration during 1 week before enrollment.

结局指标

主要结局

Mean concentration of Pregnancy-associated Plasma Protein A (PAPP A)

时间窗: 0 month

Mean concentration of Asymmetric Dimethylarginine (ADMA)

时间窗: 0 month

Mean concentration of Lipprotein (a)

时间窗: 0 month

Mean concentration of Lipoprotein-associated Phospholipase A2 (LP-PL-A2)

时间窗: 0 month

Mean concentration of highsensitivity C-reactive Protein (hsCRP)

时间窗: 0 month

次要结局

未报告次要终点

研究者

发起方
St. Petersburg State Pavlov Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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