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采用微计算机断层扫描定量评估 ST 段抬高型心肌梗死患者血栓负荷的前瞻性观察性研究的原理和设计:QUEST-STEMI 试验。

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.

机构信息

First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.

Hellenic Centre for Marine Research, Former US Base at Gournes, 71003, Heraklion, Greece.

出版信息

BMC Cardiovasc Disord. 2020 Mar 11;20(1):125. doi: 10.1186/s12872-020-01393-5.

DOI:10.1186/s12872-020-01393-5
PMID:32160856
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7065303/
Abstract

BACKGROUND

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.

METHODS

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.

DISCUSSION

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.

TRIAL REGISTRATION

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).

摘要

背景

虽然 ST 段抬高型心肌梗死(STEMI)患者存在血栓与不良结局相关,但常规血栓抽吸并未被证明有效。一种潜在的解释是这些患者应该进行风险分层。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。抽吸的血栓物质特征可能是另一个尚未解决的重要参数。在本报告中,我们旨在描述使用微计算机断层扫描(micro-CT)对接受直接经皮冠状动脉介入治疗(PCI)的患者的冠状动脉内抽吸血栓进行的方法学分析。这些数据将与传统因素结合起来,为这些患者开发一种具有高判别能力的风险分层系统。

方法

希腊 AHEPA 大学医院将招募 87 名 STEMI 患者进行血栓抽吸。第一例患者于 2018 年 6 月入组。抽吸后,血栓用福尔马林保存,并通过 micro-CT 计算其体积和密度。micro-CT 允许我们从一系列 X 射线投影图像中创建血栓的 3D 模型。这些模型进一步分析以找到提取血栓的体积和密度,并评估其结构的潜在差异。将这些变量与临床参数和血管造影结果进行关联。

讨论

QUEST-STEMI 是迄今为止首例使用 micro-CT 评估容积性冠状动脉血栓的研究。这种方法可用于更大规模的临床导向试验中,以帮助根据不良结局风险对具有血栓负荷的患者进行分层。

试验注册

QUEST-STEMI 试验 ClinicalTrials.gov 编号:NCT03429608 注册日期:2018 年 2 月 12 日。该研究前瞻性注册(在纳入第一个参与者之前)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bcfb/7065303/bae0651c7cea/12872_2020_1393_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bcfb/7065303/bae0651c7cea/12872_2020_1393_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bcfb/7065303/bae0651c7cea/12872_2020_1393_Fig1_HTML.jpg

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