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临床试验/NCT01915862
NCT01915862已完成不适用

Comparison of Blood Pressure Variability Indices and Ambulatory Arterial Stiffness Index as Prognostic Indicators in the Medium Term Outcome of Acute Ischemic Stroke

Aristotle University Of Thessaloniki3 个研究点 分布在 1 个国家目标入组 353 人开始时间: 2013年8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
353
试验地点
3
主要终点
Modified Rankin Scale Score (mRS)

研究概览

简要总结

The purpose of this study is the evaluation and comparison of blood pressure variability indices and ambulatory arterial stiffness index obtained by ambulatory blood pressure monitoring as prognostic indicators in the functional outcome of acute ischemic stroke.

详细描述

All consecutive patients admitted with acute (within 24 hours after stroke onset) ischemic stroke in three University Hospital of Northern and Central Greece will be included.

Blood pressure measurements are being obtained with ambulatory 24-hour BP monitoring (ABPM) every 20 minutes within 24 hours of admission using automated oscillometric device (TM2430, A&D Company Ltd) during day-time (7:00-22:59) and night-time (23:00-6:59).

Several clinical, laboratory and imaging parameters are prospectively registered. Also, patients' medical history, previous medical treatment and cardiovascular risk factors are registered.

Functional outcome is assessed by the modified Rankin Scale score at 3 months. Also, stroke recurrence and cardiovascular and all-cause mortality will be assessed.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute ischemic stroke
  • Admission within 24 after the onset of symptoms

排除标准

  • Transient ischemic attack
  • Intracerebral hemorrhage
  • Subarachnoid hemorrhage
  • Cerebral sinus venous thrombosis
  • Stroke mimics
  • Late admission (>24 hours after stroke onset)

结局指标

主要结局

Modified Rankin Scale Score (mRS)

时间窗: Three months (90 days)

Description (score) * No symptoms at all (0) * No significant disability despite symptoms; able to carry out all usual duties and activities (1) * Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance (2) * Moderate disability; requiring some help, but able to walk without assistance (3) * Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance (4) * Severe disability; bedridden, incontinent and requiring constant nursing care and attention(5) * Dead (6)

次要结局

未报告次要终点

研究者

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

Nikolaos Kakaletsis

MD, MSc, Resident in Internal Medicine, AHEPA University Hospital

Aristotle University Of Thessaloniki

研究点 (3)

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Blood Pressure Variability in Acute Ischemic Stroke | 临床试验