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ICARUSS,即降低二次中风综合护理试验:一项针对近期脑血管事件患者预防复发性中风的多模式干预随机对照试验的原理与设计,澳大利亚临床试验注册编号=12611000264987。

ICARUSS, the Integrated Care for the Reduction of Secondary Stroke trial: rationale and design of a randomized controlled trial of a multimodal intervention to prevent recurrent stroke in patients with a recent cerebrovascular event, ACTRN = 12611000264987.

作者信息

Joubert J, Davis S M, Hankey G J, Levi C, Olver J, Gonzales G, Donnan G A

机构信息

Departments of Medicine and Neurology, University of Melbourne, Melbourne, Victoria, Australia.

Department of Neurology, Royal Melbourne Hospital, Parkville, Victoria, Australia.

出版信息

Int J Stroke. 2015 Jul;10(5):773-7. doi: 10.1111/ijs.12510. Epub 2015 Apr 23.

DOI:10.1111/ijs.12510
PMID:25907853
Abstract

BACKGROUND

The majority of strokes, both ischaemic and haemorrhagic, are attributable to a relatively small number of risk factors which are readily manageable in primary care setting. Implementation of best-practice recommendations for risk factor management is calculated to reduce stroke recurrence by around 80%. However, risk factor management in stroke survivors has generally been poor at primary care level. A model of care that supports long-term effective risk factor management is needed.

AIM

To determine whether the model of Integrated Care for the Reduction of Recurrent Stroke (ICARUSS) will, through promotion of implementation of best-practice recommendations for risk factor management reduce the combined incidence of stroke, myocardial infarction and vascular death in patients with recent stroke or transient ischaemic attack (TIA) of the brain or eye.

DESIGN

A prospective, Australian, multicentre, randomized controlled trial.

SETTING

Academic stroke units in Melbourne, Perth and the John Hunter Hospital, New South Wales.

SUBJECTS

1000 stroke survivors recruited as from March 2007 with a recent (<3 months) stroke (ischaemic or haemorrhagic) or a TIA (brain or eye).

RANDOMIZATION

Randomization and data collection are performed by means of a central computer generated telephone system (IVRS).

INTERVENTION

Exposure to the ICARUSS model of integrated care or usual care.

PRIMARY OUTCOME

The composite of stroke, MI or death from any vascular cause, whichever occurs first.

SECONDARY OUTCOMES

Risk factor management in the community, depression, quality of life, disability and dementia.

STATISTICAL POWER

With 1000 patients followed up for a median of one-year, with a recurrence rate of 7-10% per year in patients exposed to usual care, the study will have at least 80% power to detect a significant reduction in primary end-points

CONCLUSION

The ICARUSS study aims to recruit and follow up patients between 2007 and 2013 and demonstrate the effectiveness of exposure to the ICARUSS model in stroke survivors to reduce recurrent stroke or vascular events and promote the implementation of best practice risk factor management at primary care level.

摘要

背景

大多数中风,包括缺血性和出血性中风,都可归因于相对较少的风险因素,这些因素在初级保健环境中易于管理。实施针对风险因素管理的最佳实践建议预计可将中风复发率降低约80%。然而,中风幸存者的风险因素管理在初级保健层面通常较差。需要一种支持长期有效风险因素管理的护理模式。

目的

确定降低复发性中风综合护理模式(ICARUSS)是否会通过促进实施针对风险因素管理的最佳实践建议,降低近期发生中风或短暂性脑缺血发作(TIA)或眼部TIA的患者中风、心肌梗死和血管性死亡的综合发生率。

设计

一项前瞻性、澳大利亚多中心随机对照试验。

地点

墨尔本、珀斯的学术性中风单元以及新南威尔士州的约翰·亨特医院。

研究对象

从2007年3月起招募的1000名中风幸存者,近期(<3个月)有中风(缺血性或出血性)或TIA(脑部或眼部)。

随机分组

通过中央计算机生成的电话系统(IVRS)进行随机分组和数据收集。

干预措施

接受ICARUSS综合护理模式或常规护理。

主要结局

中风、心肌梗死或任何血管原因导致的死亡,以先发生者为准的综合结局。

次要结局

社区中的风险因素管理、抑郁、生活质量、残疾和痴呆。

统计效能

对1000名患者进行为期一年的中位随访,接受常规护理的患者每年复发率为7 - 10%,该研究将至少有80%的效能检测到主要终点的显著降低。

结论

ICARUSS研究旨在在2007年至2013年期间招募并随访患者,证明中风幸存者接受ICARUSS模式可有效降低复发性中风或血管事件,并促进初级保健层面最佳实践风险因素管理的实施。

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