e-STROKE研究:一项前瞻性观察性多中心研究的设计

IF 2.6 4区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Journal of Cardiovascular Development and Disease Pub Date : 2025-01-03 DOI:10.3390/jcdd12010017
Kateřina Dvorníková, Veronika Kunešová, Svatopluk Ostrý, Robert Mikulík, Michal Bar
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引用次数: 0

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e-ASPECT、CT灌注(CTP)、侧支血流状态以及缺血性病变的大小和位置)对缺血性脑卒中患者临床结局的影响,并在脑卒中后3个月采用改良的Rankins量表(mRS)进行评估。本研究还旨在探讨多模态CT成像是否会增加再通治疗的患者数量。分析将整合来自RES-Q注册表的数据和来自Brainomix Ltd.提供的e-STROKE系统的放射学数据。目的:主要目的是确定CT参数(e-ASPECTS、CTP、侧支血管状态、缺血性病变体积和位置)对再通治疗(IVT和/或MT)后非腔隙性卒中患者三个月功能预后的预测价值。第二个目的是评估多模态CT检查是否会增加接受再通治疗的患者数量。此外,本研究旨在评估多模态CT在区分卒中模拟和实际卒中中的特异性和敏感性。方法:这项多中心观察性研究纳入了疑似急性缺血性卒中且病前mRS≤4的患者,这些患者在捷克卒中研究网络(STROCZECH)内的卒中中心接受血管内血栓切除术(EVT)、静脉溶栓(IVT)或保守治疗,该网络是捷克临床研究基础设施网络(CZECRIN)的一部分。数据收集包括人口统计学、临床和影像学数据变量,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结果、卒中病因、e-ASPECTS、急性缺血体积(AIV)、NCCT上血栓长度、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、错配比和体积、最终梗死体积、出血量、随访NCCT阴性时进行MRI检查。结论:我们预计在12个月的时间里从22个中心的约2000名患者中收集可靠的临床和放射学数据。该结果有望提高急性脑卒中诊断和预后放射标志物的准确性。
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The e-STROKE Study: The Design of a Prospective Observational Multicentral Study.

Introduction: 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. Aims: 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. Methods: 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. Conclusions: 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.

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来源期刊
Journal of Cardiovascular Development and Disease
Journal of Cardiovascular Development and Disease CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
2.60
自引率
12.50%
发文量
381
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