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急性缺血性中风与心脏病关系的评估——一项前瞻性观察性试验方案

Assessment of relationship between acute ischemic stroke and heart disease--protocol of a prospective observational trial.

作者信息

Kral Michal, Skoloudik David, Sanak Daniel, Veverka Tomas, Bartkova Andrea, Dornak Tomas, Hutyra Martin, Vindis David, Ulehlova Jana, Slavik Ludek, Svabova Marija, Kubickova Veronika, Herzig Roman, Kanovsky Petr

机构信息

Comprehensive Stroke Center, Department of Neurology, University Hospital Olomouc and Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic.

出版信息

Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2012 Sep;156(3):284-9. doi: 10.5507/bp.2012.094. Epub 2012 Oct 4.

DOI:10.5507/bp.2012.094
PMID:23069890
Abstract

BACKGROUND

Stroke and acute myocardial infarction are the leading causes of death and disability in industrialized countries. Multiple interactions exist between the various forms of cardiovascular and cerebrovascular diseases, and risk factors for development of stroke and major cardiovascular events are similar. There is currently no clear link between acute coronary syndrome and stroke, although it has been repeatedly described. In addition, there are currently no clear recommendations for how to proceed in the case of signs of myocardial damage in patients with acute stroke and how to manage the next follow-up. METHODS-DESIGN: In this prospective observational trial, 500 consecutive ischemic stroke patients admitted at the Comprehensive Stroke Center will be enrolled within 12 h from stroke onset. The set of examinations will consist of: 1) Acute brain computed tomography or magnetic resonance imaging 2) Laboratory tests: A) within 12 h from stroke onset: NT pro B-type of natriuretic peptide, pro-atrial natriuretic peptide, creatinekinase MB, troponin T (cTnT), interleukin 6, procalcitonin, high sensitive C-reactive protein and D-dimers. B) control level of cTnT after 4 h from admission C) non-acute laboratory samples within 60 h from stroke onset: glycated haemoglobine, serum lipids; 3) Electrocardiogram (ECG) on admission and 4 h from stroke onset; 4) Transesophageal or transthoracal echocardiography and 24-h ECG-Holter within 15 days from stroke onset; 5) Neurosonological examination within 60 h from stroke onset; 6) Thirty patients with a positive finding of acute myocardial ischemia (ECG, cTnT) will be examined by coronary angiography (CAG); 7) Epidemiological data will be acquired.

STATISTICS

The epidemiological characteristics of the whole sample of patients; correlation between differences between group of cardioembolic ischemic stroke patients and group of patients with ischemic stroke of another etiology; correlation of infarction volume on DWI-MRI with the level of cTnT; correlation of the ECG findings with the level of cTnT and clinical signs; correlation of the CAG findings with level of cTnT and ECG findings will be statistically evaluated at the 5% level of statistical significance.

CONCLUSION

The main goal of the project is to improve identification of patients with acute coronary syndrome and with concurrent acute ischemic stroke as these patients require specific treatment and secondary prevention of ischemic events.

TRIAL REGISTRATION

Clinicaltrials.gov NCT01541163.

摘要

背景

在工业化国家,中风和急性心肌梗死是导致死亡和残疾的主要原因。心血管和脑血管疾病的多种形式之间存在多种相互作用,中风和主要心血管事件发生的危险因素相似。尽管急性冠状动脉综合征与中风之间的联系已被多次描述,但目前尚无明确关联。此外,对于急性中风患者出现心肌损伤迹象时如何处理以及如何进行后续随访,目前也没有明确的建议。

方法 - 设计:在这项前瞻性观察性试验中,综合卒中中心连续收治的500例缺血性中风患者将在中风发作后12小时内入组。检查项目包括:1)急性脑计算机断层扫描或磁共振成像;2)实验室检查:A)中风发作后12小时内:N末端B型利钠肽原、心房利钠肽原、肌酸激酶同工酶MB、肌钙蛋白T(cTnT)、白细胞介素6、降钙素原、高敏C反应蛋白和D - 二聚体。B)入院4小时后cTnT的对照水平。C)中风发作后60小时内的非急性实验室样本:糖化血红蛋白、血脂;3)入院时及中风发作后4小时的心电图(ECG);4)中风发作后15天内的经食管或经胸超声心动图及24小时动态心电图监测;5)中风发作后60小时内的神经超声检查;6)30例急性心肌缺血(ECG、cTnT)检查结果呈阳性的患者将接受冠状动脉造影(CAG)检查;7)收集流行病学数据。

统计学

将对患者全样本的流行病学特征;心源性栓塞性缺血性中风患者组与其他病因的缺血性中风患者组之间差异的相关性;DWI - MRI上梗死体积与cTnT水平的相关性;ECG检查结果与cTnT水平及临床体征的相关性;CAG检查结果与cTnT水平及ECG检查结果的相关性进行统计学评估,统计学显著性水平为5%。

结论

该项目的主要目标是改善对急性冠状动脉综合征合并急性缺血性中风患者的识别,因为这些患者需要特定的治疗和缺血事件的二级预防。

试验注册

Clinicaltrials.gov NCT01541163。

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