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临床试验/NCT03925298
NCT03925298已完成不适用

Troponin- I Elevation Predicts Outcome After Thrombolysis in Stroke Patients

Zagazig University0 个研究点目标入组 81 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
81
主要终点
good neurological Outcome after thrombolysis

研究概览

简要总结

Elevated level of serum troponin (T-I) has been regarded as a prognostic biomarker of poor outcome in acute ischemic stroke. However, its role in outcome in thrombolysed ischemic stroke patients remains uncertain. The aim of this study was to evaluate the role of T-I as a predictive biomarker of short-term outcome in thrombolysed ischemic stroke participants.

详细描述

Elevated level of serum troponin (T-I) has been regarded as a prognostic biomarker of poor outcome in acute ischemic stroke. However, its role in outcome in thrombolysed ischemic stroke patients remains uncertain. The aim of this study was to evaluate the role of T-I as a predictive biomarker of short-term outcome in thrombolysed ischemic stroke patients. Methods: This study included 72 acute ischemic stroke participants were treated with intravenous thrombolytic therapy. All participants were subjected to general and neurological evaluation including assessment of stroke severity using National Institute of Health Stroke Scale (NIHSS) at admission and investigations including measurement of serum level of T-I on admission. Outcome was assessed three months after stroke onset using NIHSS and modified Rankin scale (mRS).

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

  • Participants were eligible for inclusion in the study if they had evidence suggesting acute ischemic stroke that lasted for ≤ 4.5 hours .
  • Those Participants were treated with intravenous thrombolytic therapy ((recombinant tissue plasminogen activator (rt-PA)).

排除标准

  • Those who had hemorrhagic stroke
  • participants presented with acute myocardial infarction, cerebrovascular stroke in the previous three months.
  • serious head trauma in the previous three months.
  • urinary tract, lung, or gastrointestinal hemorrhage within the three weeks.
  • serious trauma or major surgery within the previous two weeks.
  • lumbar or arterial puncture at a non-compressible site within one week.
  • those received heparin within 48 hours, resulting in an activated partial thromboplastin time greater than the upper limit of normal.
  • systolic pressure > 185 mmHg or diastolic pressure > 110 mmHg.
  • blood glucose <50 or > 400 mg/dL.
  • current use of anticoagulants with an International Normalized Ratio > 1.7 or prothrombin time>15 sec; platelet count < 100,000/mm
  • pregnancy; serious heart, lung, kidney or other organ dysfunction.
  • allergy to active ingredients of rt-PA; patients with > 4.5 hours from the last time known to be asymptomatic.
  • those in whom troponin was not measured at admission were excluded from the study

结局指标

主要结局

good neurological Outcome after thrombolysis

时间窗: three months

Neurological Outcome was assessed by National Institute of Health Stroke Scale (NIHSS) . good outcome (neurological improvement) was defined as 8 points improvement in NIHSS

poor neurological Outcome after thrombolysis

时间窗: three months

Neurological Outcome was assessed by the modified Rankin Scale (mRS). The modified Rankin Scale consists of 6 grades, from 0 to 5, with the best score 0 (corresponding to no symptoms) and the worst score 5 (corresponding to severe disability). Poor outcome was defined as death or disability (mRS scores ≥2).

次要结局

未报告次要终点

研究者

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

rania sanad

Principal Investigator

Zagazig University

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