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Rationale and design of a prospective, observational study for the QUantitative EStimation of Thrombus burden in patients with ST-Elevation Myocardial Infarction using micro-computed tomography: the QUEST-STEMI trial
BMC Cardiovascular Disorders ( IF 2.0 ) Pub Date : 2020-03-11 , DOI: 10.1186/s12872-020-01393-5
Efstratios Karagiannidis , Nikolaos V. Konstantinidis , Georgios Sofidis , Evangelia Chatzinikolaou , Georgios Sianos

Although the presence of thrombus in patients with ST-elevation myocardial infarction (STEMI) has been linked to adverse outcomes, routine thrombus aspiration has not been proven effective. A potential explanation is that these patients should be risk-stratified. Traditional clinical, laboratory and angiographic parameters used in clinical trials have been proven inadequate to classify patients. Aspirated thrombotic material characteristics might be an additional important parameter that has not yet been addressed. In this report, we aim to describe a methodological analysis of thrombus aspirated from coronary arteries during primary PCI using micro-Computed Τomography (micro-CT). These data will be combined with traditional factors to develop a risk-stratification system with high discriminative power for these patients. Eighty-seven patients with STEMI undergoing thrombus aspiration in AHEPA University Hospital, Greece, will be enrolled in the study. The first patient was enrolled in June 2018. After being aspirated, thrombi are preserved in formalin and their volume and density are calculated with micro-CT. Micro-CT allows us to create 3D models of thrombi from a series of x-ray projection images. These models are further analyzed to find the volume and density of extracted thrombi and to assess potential differences in their structure. Association of these variables with clinical parameters and angiographic outcomes will be explored. QUEST-STEMI is-to our knowledge-the first study of volumetric coronary thrombus assessment by micro-CT. This method could be used in larger, clinically-oriented trials to help stratify patients with thrombus burden according to their risk for adverse outcomes. QUEST-STEMI trial ClinicalTrials.gov number: NCT03429608 Date of registration: February 12, 2018. The study was prospectively registered (registered prior to enrollment of the first participant).

中文翻译:

使用微型计算机断层摄影术定量评估ST抬高型心肌梗死患者血栓负担的定量前瞻性观察研究的原理和设计:QUEST-STEMI试验

尽管ST抬高型心肌梗死(STEMI)患者存在血栓与不良结局有关,但常规血栓抽吸术尚未被证明有效。可能的解释是这些患者应进行风险分层。临床试验中使用的传统临床,实验室和血管造影参数已被证明不足以对患者进行分类。吸入性血栓物质特性可能是尚未解决的另一个重要参数。在本报告中,我们旨在描述使用微型计算机断层扫描(micro-CT)技术在原发PCI期间从冠状动脉抽吸的血栓的方法学分析。这些数据将与传统因素结合起来,为这些患者开发具有高判别力的风险分层系统。将在希腊AHEPA大学医院接受血栓抽吸的87例STEMI患者入选本研究。首例患者于2018年6月入选。吸出后,血栓保存在福尔马林中,并用micro-CT计算其体积和密度。Micro-CT允许我们根据一系列X射线投影图像创建血栓的3D模型。对这些模型进行进一步分析,以找到提取出的血栓的体积和密度,并评估其结构的潜在差异。将探讨这些变量与临床参数和血管造影结果之间的关系。就我们所知,QUEST-STEMI是第一个通过微CT评估冠状动脉血栓的研究。这种方法可以用于较大的 以临床为导向的试验,可根据血栓负担不良反应的风险对患者进行分层。QUEST-STEMI试验ClinicalTrials.gov编号:NCT03429608注册日期:2018年2月12日。该研究经过前瞻性注册(在首次参加者注册之前进行了注册)。
更新日期:2020-03-12
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