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电子卒中研究:一项前瞻性观察性多中心研究的设计

The e-STROKE Study: The Design of a Prospective Observational Multicentral Study.

作者信息

Dvorníková Kateřina, Kunešová Veronika, Ostrý Svatopluk, Mikulík Robert, Bar Michal

机构信息

Department of Neurology, University Hospital in Ostrava, 70800 Ostrava, Czech Republic.

Cerebrovascular Research Program, International Clinical Research Center, 65691 Brno, Czech Republic.

出版信息

J Cardiovasc Dev Dis. 2025 Jan 3;12(1):17. doi: 10.3390/jcdd12010017.

DOI:10.3390/jcdd12010017
PMID:39852295
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11766030/
Abstract

The e-STROKE study is a prospective, multicenter observational study designed to assess the impact of various CT parameters (including e-ASPECT, CT perfusion (CTP), collateral flow status, and the size and location of the ischemic lesion) on the clinical outcomes of patients with ischemic stroke, as evaluated by the modified Rankins Scale (mRS) three months post-stroke. This study also aims to investigate whether the use of multimodal CT imaging increases the number of patients eligible for recanalization therapy. The analysis will integrate data from the RES-Q registry and radiological data from the e-STROKE system provided by Brainomix Ltd. The primary aim is to determine the predictive value of CT parameters (e-ASPECTS, CTP, collateral vessel status, and ischemic lesion volume and location) on three-month functional outcomes, as defined by the mRS, in patients with non-lacunar stroke following recanalization treatment (IVT and/or MT). The secondary aim is to evaluate whether multimodal CT examination leads to an increase in the number of patients eligible for recanalization therapy. Additionally, this study seeks to assess the specificity and sensitivity of multimodal CT in distinguishing stroke mimics from actual strokes. This multicenter observational study involves patients with suspected acute ischemic stroke and a premorbid mRS ≤ 4, who are treated with endovascular thrombectomy (EVT), intravenous thrombolysis (IVT), or managed conservatively in stroke centers within the Czech Stroke Research Network (STROCZECH), which is part of the Czech Clinical Research Infrastructure Network (CZECRIN). Data collection includes demographic, clinical, and imaging data variables such as age, sex, ethnicity, risk factors, treatment times (OTT, DNT, and OGT), TICI scores, post-treatment hemorrhage (ECAS II), mRS outcome, stroke etiology, e-ASPECTS, acute ischemic volume (AIV), thrombus length on NCCT, CTA collateral score and collateral vessel density, location of large vessel occlusion, ischemic core, hypoperfusion volume, mismatch ratio and volume, final infarct volume, hemorrhage volume, and MRI in case of negative follow-up NCCT. We anticipate collecting robust clinical and radiological data from approximately 2000 patients across 22 centers over a 12-month period. The results are expected to enhance the precision of diagnostic and prognostic radiological markers in managing acute stroke.

摘要

e-STROKE研究是一项前瞻性、多中心观察性研究,旨在评估各种CT参数(包括电子ASPECT、CT灌注(CTP)、侧支血流状态以及缺血性病变的大小和位置)对缺血性中风患者临床结局的影响,中风后三个月通过改良Rankin量表(mRS)进行评估。本研究还旨在调查使用多模态CT成像是否会增加符合再通治疗条件的患者数量。该分析将整合来自RES-Q注册中心的数据以及Brainomix有限公司提供的e-STROKE系统的放射学数据。主要目的是确定CT参数(电子ASPECTS、CTP、侧支血管状态以及缺血性病变体积和位置)对非腔隙性中风患者再通治疗(静脉溶栓和/或机械取栓)后三个月功能结局(由mRS定义)的预测价值。次要目的是评估多模态CT检查是否会增加符合再通治疗条件的患者数量。此外,本研究旨在评估多模态CT在区分中风模拟物与实际中风方面的特异性和敏感性。这项多中心观察性研究涉及疑似急性缺血性中风且病前mRS≤4的患者,这些患者在捷克中风研究网络(STROCZECH,捷克临床研究基础设施网络(CZECRIN)的一部分)内的中风中心接受血管内血栓切除术(EVT)、静脉溶栓(IVT)或保守治疗。数据收集包括人口统计学、临床和影像数据变量,如年龄、性别、种族、危险因素、治疗时间(OTT、DNT和OGT)、TICI评分、治疗后出血(ECAS II)、mRS结局、中风病因、电子ASPECTS、急性缺血体积(AIV)、非增强CT上的血栓长度、CTA侧支评分和侧支血管密度、大血管闭塞位置、缺血核心、低灌注体积、不匹配率和体积、最终梗死体积、出血体积,以及随访非增强CT为阴性时的MRI。我们预计在12个月内从22个中心的约2000名患者中收集可靠的临床和放射学数据。预期结果将提高管理急性中风时诊断和预后放射学标志物的准确性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e471/11766030/e3787e1347c4/jcdd-12-00017-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e471/11766030/e3787e1347c4/jcdd-12-00017-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e471/11766030/e3787e1347c4/jcdd-12-00017-g001.jpg

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Effectiveness of computed tomography perfusion imaging in stroke management.计算机断层扫描灌注成像在卒中管理中的有效性。
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