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2020年负荷超声心动图:缺血性和非缺血性心脏病国际负荷超声心动图研究

Stress echo 2020: the international stress echo study in ischemic and non-ischemic heart disease.

作者信息

Picano Eugenio, Ciampi Quirino, Citro Rodolfo, D'Andrea Antonello, Scali Maria Chiara, Cortigiani Lauro, Olivotto Iacopo, Mori Fabio, Galderisi Maurizio, Costantino Marco Fabio, Pratali Lorenza, Di Salvo Giovanni, Bossone Eduardo, Ferrara Francesco, Gargani Luna, Rigo Fausto, Gaibazzi Nicola, Limongelli Giuseppe, Pacileo Giuseppe, Andreassi Maria Grazia, Pinamonti Bruno, Massa Laura, Torres Marco A R, Miglioranza Marcelo H, Daros Clarissa Borguezan, de Castro E Silva Pretto José Luis, Beleslin Branko, Djordjevic-Dikic Ana, Varga Albert, Palinkas Attila, Agoston Gergely, Gregori Dario, Trambaiolo Paolo, Severino Sergio, Arystan Ayana, Paterni Marco, Carpeggiani Clara, Colonna Paolo

机构信息

Institute of Clinical Physiology, National Research Council, Pisa, Italy.

Cardiology Division, Fatebenefratelli Hospital, Benevento, Italy.

出版信息

Cardiovasc Ultrasound. 2017 Jan 18;15(1):3. doi: 10.1186/s12947-016-0092-1.

Abstract

BACKGROUND

Stress echocardiography (SE) has an established role in evidence-based guidelines, but recently its breadth and variety of applications have extended well beyond coronary artery disease (CAD). We lack a prospective research study of SE applications, in and beyond CAD, also considering a variety of signs in addition to regional wall motion abnormalities.

METHODS

In a prospective, multicenter, international, observational study design, > 100 certified high-volume SE labs (initially from Italy, Brazil, Hungary, and Serbia) will be networked with an organized system of clinical, laboratory and imaging data collection at the time of physical or pharmacological SE, with structured follow-up information. The study is endorsed by the Italian Society of Cardiovascular Echography and organized in 10 subprojects focusing on: contractile reserve for prediction of cardiac resynchronization or medical therapy response; stress B-lines in heart failure; hypertrophic cardiomyopathy; heart failure with preserved ejection fraction; mitral regurgitation after either transcatheter or surgical aortic valve replacement; outdoor SE in extreme physiology; right ventricular contractile reserve in repaired Tetralogy of Fallot; suspected or initial pulmonary arterial hypertension; coronary flow velocity, left ventricular elastance reserve and B-lines in known or suspected CAD; identification of subclinical familial disease in genotype-positive, phenotype- negative healthy relatives of inherited disease (such as hypertrophic cardiomyopathy).

RESULTS

We expect to recruit about 10,000 patients over a 5-year period (2016-2020), with sample sizes ranging from 5,000 for coronary flow velocity/ left ventricular elastance/ B-lines in CAD to around 250 for hypertrophic cardiomyopathy or repaired Tetralogy of Fallot. This data-base will allow to investigate technical questions such as feasibility and reproducibility of various SE parameters and to assess their prognostic value in different clinical scenarios.

CONCLUSIONS

The study will create the cultural, informatic and scientific infrastructure connecting high-volume, accredited SE labs, sharing common criteria of indication, execution, reporting and image storage of SE to obtain original safety, feasibility, and outcome data in evidence-poor diagnostic fields, also outside the established core application of SE in CAD based on regional wall motion abnormalities. The study will standardize procedures, validate emerging signs, and integrate the new information with established knowledge, helping to build a next-generation SE lab without inner walls.

摘要

背景

负荷超声心动图(SE)在循证指南中具有既定作用,但近来其应用范围和种类已远远超出冠状动脉疾病(CAD)。我们缺乏一项关于SE在CAD内外应用的前瞻性研究,该研究还需考虑除节段性室壁运动异常之外的各种体征。

方法

在一项前瞻性、多中心、国际性观察性研究设计中,超过100个经认证的高容量SE实验室(最初来自意大利、巴西、匈牙利和塞尔维亚)将通过一个有组织的系统在进行运动或药物负荷SE时收集临床、实验室和影像数据,并获取结构化的随访信息。该研究得到了意大利心血管超声学会的认可,并组织为10个子项目,重点关注:用于预测心脏再同步化或药物治疗反应的收缩储备;心力衰竭中的负荷B线;肥厚型心肌病;射血分数保留的心力衰竭;经导管或外科主动脉瓣置换术后的二尖瓣反流;极端生理学条件下的户外SE;法洛四联症修复术后的右心室收缩储备;疑似或初发肺动脉高压;已知或疑似CAD中的冠状动脉血流速度、左心室弹性储备和B线;在遗传性疾病(如肥厚型心肌病)的基因型阳性、表型阴性健康亲属中识别亚临床家族性疾病。

结果

我们预计在5年期间(2016 - 2020年)招募约10000名患者,样本量从CAD中冠状动脉血流速度/左心室弹性/B线的5000例到肥厚型心肌病或法洛四联症修复术的约250例不等。这个数据库将有助于研究各种SE参数的可行性和可重复性等技术问题,并评估它们在不同临床场景中的预后价值。

结论

该研究将创建文化、信息和科学基础设施,连接高容量、经认可的SE实验室,共享SE的适应证、执行、报告和图像存储的共同标准,以在证据不足的诊断领域获得原始的安全性、可行性和结局数据,这些领域也超出了基于节段性室壁运动异常的SE在CAD中的既定核心应用。该研究将规范程序,验证新出现的体征,并将新信息与现有知识整合,有助于建立一个没有内部壁垒的下一代SE实验室。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/960a/5242057/1456ef9836b9/12947_2016_92_Fig1_HTML.jpg

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