Additive Anti-inflammatory Action for Aortopathy & Arteriopathy

Recruiting now

Conditions studied: Acute Aortic Syndrome

In brief

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. Twenty Chinese cardiovascular centers have collaborated to create a multicenter observational registry (named Chinese registry of Additive Anti-inflammatory Action for Aortopathy \& Arteriopathy \[5A\]), 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.

Key facts

Study ID

NCT04398992

Run by

Nanjing Medical University

People needed

10000

Starts

2016-01-01

Expected to finish

2030-12-31

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 years or older.
• Patients with diagnosis of AAS, including aortic dissection, penetrating aortic ulcer or intramural hematoma.
• Symptoms started within 14 days from surgery.
• Patients received medical therapy, open surgical, endovascular, or hybrid repair.
• Any other major cardiac surgical procedure concomitant with surgery for AAS, such as coronary artery bypass grafting or carotid artery replacement;
• The patient or guardian agrees to participate in this study. Exclusion criteria
• Patients aged < 18 years.
• Onset of symptoms > 14 days from surgery.
• AAS secondary to traumatic or iatrogenic injury.
• Patients who declined participation in registration and follow-up investigation.

Where it is running

• Beijing Fuwai Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
• Chongqing Hospital of Jiangsu Provincial People's Hospital — Chongqing, Chongqing Municipality, China (enrolling)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (enrolling)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (enrolling)
• QianXiNan People's Hospital — Xingyi, Guizhou, China (enrolling)
• The Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (enrolling)
• The Third Affiliated Hospital of Soochow University — Changzhou, Jiangsu, China (enrolling)
• Suqian Hospital of of Nanjing Medical University — Suqian, Jiangsu, China (enrolling)
• Dongtai People's Hospital — Yancheng, Jiangsu, China (enrolling)
• Subei People's Hospital of Jiangsu Province — Yangzhou, Jiangsu, China (enrolling)
• the Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)
• Shanghai DeltaHealth Hospital — Shanghai, Shanghai Municipality, China (enrolling)
• Shanxi Cardiovascular Hospital — Taiyuan, Shanxi, China (enrolling)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)
• The Seventh Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (enrolling)
• The Friendship Hospital of Yili Kazak Autonomous Prefecture — Yining, Xinjiang, China (enrolling)
• The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (enrolling)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (enrolling)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (enrolling)
• Beijing Anzhen Hospital Capital Medical University — Beijing, China (enrolling)
• Beijing Chaoyang Hospital — Beijing, China (enrolling)
• the First Affiliated Hospital of Bengbu Medical College — Bengbu, China (enrolling)
• Nanjing First Hospital, Nanjing Medical University — Nanjing, China (enrolling)
• the First Affiliated Hospital of Shantou University Medical College — Shantou, China (enrolling)

Full record on ClinicalTrials.gov

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