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临床试验/NCT03355690
NCT03355690已完成不适用

The Care of Stroke in the Hospital of Genk: Outcome After Treatment and the Health-economic Impact of Stroke in the Patient Population

Ziekenhuis Oost-Limburg1 个研究点 分布在 1 个国家目标入组 564 人开始时间: 2017年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
564
试验地点
1
主要终点
Modified rankin scale

研究概览

简要总结

A stroke occurs when the blood circulation is hampered due an ischemic or hemorrhagic event. Previous, a stroke was treated only with anti-aggregation. Over time, multiple studies have showed a positive effect of intravenous thrombolysis with rt-PA (recombinant tissue plasminogen activator) in comparison with the standard treatment (anti-aggregation). Since 2015, thrombectomy was proven to have an added value in combination with thrombolysis. Thrombectomy is an endovascular technique where the thrombus is removed or fragmented.

Diagnosis and treatment of stroke will have a significant impact on the health-economic status of the patient. However, little data is known. Unfortunately, the outcome after diagnosis with a stroke is not well documented. Therefore, this follow-up study over a time period of one year, will give us a sufficient amount of data to evaluate patients diagnosed with a stroke in the hospital of Genk.

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 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • signed informed consent
  • older than 18 years
  • diagnosed with stroke

排除标准

  • younger than 18 years

结局指标

主要结局

Modified rankin scale

时间窗: day 1, 3 months and 12 months

Change in modified rankin scale over time: baseline (diagnosis stroke), 3 months and one year follow-up. Modified rankin scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead.

次要结局

  • Rehabilitation: evaluation muscle strength(day 1, 3 months and 12 months)
  • Rehabilitation: evaluation arm/hand function(day 1, 3 months and 12 months)
  • Quality of life-EQ5D(day 1, 3 months and 12 months)
  • National Institutes of Health Stroke Scale (NIHSS)(day 1, 3 months and 12 months)
  • Quality of life-Barthel index(day 1, 3 months and 12 months)
  • Quality of life-stroke specific quality of life scale(day 1, 3 months and 12 months)
  • Rehabilitation: walking capability(day 1, 3 months and 12 months)
  • Rehabilitation: trunk control test(day 1, 3 months and 12 months)

研究者

发起方
Ziekenhuis Oost-Limburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dieter Mesotten

MD

Ziekenhuis Oost-Limburg

研究点 (1)

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