Chinese Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Registry protocol: rationale, design and methodology

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2024年2月21日

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Hong Liu,
Si-chong Qian,
Hai-yang Li,
Yong-feng Shao,
Hong-jia Zhang,
Hong Liu,
Si-chong Qian,
Hai-yang Li,
Lu Han,
Ying-yuan Zhang,
Kai Wang,
Ying Wu,
Liang Hong,
Ji-nong Yang,
Ji-sheng Zhong,
Bing-qi Sun,
Xiao-cheng Liu,
Dong-kai Wu,
Guo-liang Fan,
Jun-quan Chen,
Sheng-qiang Zhang,
Yi-yao Jiang,
Xing-xing Peng,
Zhi-hua Zeng,
Xin Zhao,
Peng-cheng Tang,
Xiao-yan Feng,
Cheng-bin Tang,
Hui-jun Zhang,
Zhan-jie Lu,
Si-qiang Zheng,
Chen Zhang,
Yong-feng Shao,
Hong-jia Zhang,
Peng-cheng Zhu,
Hong-hua Yue,
Ling-chen Huang,
Feng Wu,
Xiao-han Xu,
Xiao-hu Lu,
Wei-dong Gu

摘要

Background

Acute aortic syndrome (AAS) is a life-threatening condition. Inflammation plays a key role in the pathogenesis, development and progression of AAS, and is associated with significant mortality and morbidity. Understanding the inflammatory responses and inflammation resolutions is essential for an appropriate management of AAS.

Method

Thirty Chinese cardiovascular centers have collaborated to create a multicenter observational registry (named Chinese Additive Anti-inflammatory Action for Aortopathy & Arteriopathy [5A] registry), with consecutive enrollment of adult patients who underwent surgery for AAS that was started on Jan 1, 2016 and will be ended on December 31, 2040. Specially, the impact of inflammation and anti-inflammatory strategies on the early and late adverse events are investigated. Primary outcomes are severe systemic inflammatory response syndrome (SIRS), multiple organ dysfunction syndrome (MODS), Sequential Organ Failure Assessment (SOFA) scores at 7 days following this current surgery. Secondary outcomes are SISR, 30-day mortality, operative mortality, hospital mortality, new-onset stroke, acute kidney injury, surgical site infection, reoperation for bleeding, blood transfusion and length of stay in the intensive care unit.

Discussion

The analysis of this multicenter registry will allow our better knowledge of the prognostic importance of preoperative inflammation and different anti-inflammatory strategies in adverse events after surgery for AAS. This registry is expected to provide insights into novel different inflammatory resolutions in management of AAS beyond conventional surgical repair.

Trial registration

ClinicalTrials.gov Identifier: NCT04398992 (Initial Release: 05/19/2020).