Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, Chaoyang-qu, Beijing, China.
Department of Cardiac Surgery, Peking University Third Hospital, Beijing, China.
BMJ Open. 2023 Jun 7;13(6):e067469. doi: 10.1136/bmjopen-2022-067469.
Acute aortic syndrome (AAS) is a group of acute and critical conditions, including acute aortic dissection (AAD), acute intramural haematoma and penetrating aortic ulcer. High mortality and morbidity rates result in a poor patient prognosis. Prompt diagnoses and timely interventions are paramount for saving patients' lives. In recent years, risk models for AAD have been established worldwide; however, a risk evaluation system for AAS is still lacking in China. Therefore, this study aims to develop an early warning and risk scoring system in combination with the novel potential biomarker soluble ST2 (sST2) for AAS.
This multicentre, prospective, observational study will recruit patients diagnosed with AAS at three tertiary referral centres from 1 January 2020 to 31 December 2023. We will analyse the discrepancies in sST2 levels in patients with different AAS types and explore the accuracy of sST2 in distinguishing between them. We will also incorporate potential risk factors and sST2 into a logistic regression model to establish a logistic risk scoring system for predicting postoperative death and prolonged intensive care unit stay in patients with AAS.
This study was registered on the Chinese Clinical Trial Registry website (http://www. chictr. org. cn/). Ethical approval was obtained from the human research ethics committees of Beijing Anzhen Hospital (KS2019016). The ethics review board of each participating hospital agreed to participate. The final risk prediction model will be published in an appropriate journal and disseminated as a mobile application for clinical use. Approval and anonymised data will be shared.
ChiCTR1900027763.
急性主动脉综合征（AAS）是一组急性和危急病症，包括急性主动脉夹层（AAD）、急性主动脉壁内血肿和穿透性主动脉溃疡。高死亡率和发病率导致患者预后不良。及时诊断和干预对于挽救患者生命至关重要。近年来，全球范围内已经建立了用于 AAD 的风险模型；然而，中国仍然缺乏用于 AAS 的风险评估系统。因此，本研究旨在结合新型潜在生物标志物可溶性 ST2（sST2），为 AAS 开发早期预警和风险评分系统。
这是一项多中心、前瞻性、观察性研究，将在 2020 年 1 月 1 日至 2023 年 12 月 31 日期间，从三家三级转诊中心招募诊断为 AAS 的患者。我们将分析不同 AAS 类型患者 sST2 水平的差异，并探讨 sST2 区分它们的准确性。我们还将把潜在的风险因素和 sST2 纳入逻辑回归模型，建立预测 AAS 患者术后死亡和延长重症监护病房住院时间的逻辑风险评分系统。
本研究在中国临床试验注册中心网站（http://www.chictr.org.cn/）上注册。本研究已获得北京安贞医院人类研究伦理委员会的批准（KS2019016）。每个参与医院的伦理审查委员会都同意参与。最终的风险预测模型将发表在适当的期刊上，并作为临床应用的移动应用程序进行传播。将共享批准和匿名数据。
ChiCTR1900027763。
