Adding anti-inflammatory treatment for acute aortic conditions

Chinese Registry of Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Protocol: Rationale, Design and Methodology

This registry will follow adults having surgery for acute aortic syndrome to see if inflammation and anti-inflammatory approaches affect recovery and complications.

Quick facts

• Study type: Observational
• Enrollment: 10000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanjing Medical University (Academic / other)
• Locations: 34 sites (Beijing, Beijing Municipality and 33 other locations)
• Trial ID: NCT04398992 on ClinicalTrials.gov

What this trial studies

A multicenter observational registry across Chinese cardiovascular centers is enrolling consecutive adults who underwent surgery for acute aortic syndrome from January 1, 2016 through December 31, 2040. The project collects clinical data, procedural details, inflammatory markers, and information on medical, open, endovascular, or hybrid treatments. Primary early outcomes include severe SIRS, multiple organ dysfunction syndrome (MODS), and SOFA scores at 7 days, with additional long-term adverse event tracking. By comparing inflammatory responses and anti-inflammatory strategies across patients, the registry aims to clarify how inflammation influences short- and long-term outcomes after AAS surgery.

Who should consider this trial

Good fit: Adults aged 18 or older who have acute aortic syndrome (aortic dissection, penetrating aortic ulcer, or intramural hematoma) with symptom onset within 14 days and who undergo medical, open, endovascular, or hybrid repair and consent to follow-up.

Not a fit: Patients with traumatic or iatrogenic acute aortic syndrome, symptom onset more than 14 days before surgery, or those who decline participation are unlikely to benefit from this registry's findings.

Why it matters

Potential benefit: If successful, this work could identify anti-inflammatory strategies that reduce postoperative inflammation, lower complications, and improve survival after surgery for acute aortic syndrome.

How similar studies have performed: Prior research supports a key role for inflammation in AAS and small studies hint that anti-inflammatory approaches may help, but a large multicenter registry focused on these questions is relatively novel.

Eligibility criteria

Inclusion criteria

* 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 this trial is running

Beijing, Beijing Municipality and 33 other locations

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

Study contacts

• Principal investigator: Hong Liu — Nanjing Medical University
• Study coordinator: Hong Liu, MD

Conditions Acute Aortic Syndrome