Additive Anti-inflammatory Action for Aortopathy & Arteriopathy

February 5, 2026 updated by: Hong Liu, Nanjing Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Aortopathy represent a major clinical challenge and are regarded as one of the leading causes of mortality among cardiovascular disorders. However, the pathological mechanisms underlying aortopathy are still far from being well understood, which makes treating this life-threatening challenging. It is increasingly clear that inflammation plays a key role in the development and progression of acute aortic syndrome (AAS) independent of cholesterol and other traditional risk factors, and characterizes both systemic and local condition.

Currently, surgery is considered the best treatment option for patients with AAS. In addition to systemic inflammatory responses triggered by AAS itself, however, procedural factors including surgical trauma, anesthesia, cardiopulmonary bypass, hypothermia, circulatory arrest, and blood transfusion as well as mechanical ventilation initiated a cascade of inflammation, which further exacerbates "inflammatory storm", and is associated with significant postoperative mortality and morbidity. Along with surgical evolutions, scientists have made new discoveries and achievements in the underlying mechanism and understanding of inflammation of AAS, which greatly encourage us to optimize treatment for these patients. Going beyond traditional surgery, anti-inflammatory action is crucially important to target the residual cardiovascular risk by specific anti-inflammatory interventions as a crucially adjunct therapeutic strategy to improve the well-being of patient.

A better understanding of the interaction between patient's inflammatory responses and anti-inflammatory strategies which may limit the residual cardiovascular risk is essential for the development of novel preventive, diagnostic, and therapeutic approaches, providing a critical pathophysiological insight into the role of inflammation in risk assessment and anti-inflammatory targeting. The epidemiological observation that biomarkers of inflammation are associated with clinical cardiovascular risk supports the theory that targeted anti-inflammatory treatment appears to be a promising strategy in reducing residual cardiovascular risk on the background of traditional surgical repair as well as basic therapy. Previous researches have shown that ulinastatin used in cardiac surgery may be effective in prevention of cardiovascular events through an anti-inflammatory effect. This residual inflammatory risk has increasingly become a viable therapeutic targeting on the background of validated surgical repair as well as basic medical therapy for AAS.

Although aortic dissection registries have been established during the last years, such as the International Registry of Acute Aortic Dissection (IRAD), the Nordic Consortium for Acute Type A Aortic Dissection (NORCAAD) Registry, German Registry for Acute Aortic Dissection type A (GERAADA), the Society of Thoracic Surgeon (STS) database , and European Registry of Type A Aortic Dissection (ERTAAD), there are currently no dedicated registry to prospective collections and characteristics of inflammatory responses, anti-inflammatory strategies, and clinical outcomes especially for AAS patients. We have established a multicenter research collaboration (named "Chinese Registry of Additive Anti-inflammatory Action for Aortopathy & Arteriopathy [5A]") and planned a prospectively observational study to understand the patient's inflammatory responses, characterize the potential anti-inflammatory strategies, and evaluate clinical outcome and prognosis of AAS patients at 15 years in a large study of Chinese population.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing chaoyang hospital
        • Contact:
          • Lu Han, MD
        • Contact:
        • Principal Investigator:
          • Lu Han, MD
      • Beijing, China
        • Recruiting
        • Beijing Anzhen Hospital Capital Medical University
        • Contact:
      • Bengbu, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
      • Changsha, China
        • Completed
        • Xiangya Hospital Central South University
      • Guangzhou, China
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guilin, China
        • Recruiting
        • the First Affiliated Hospital of Guilin Medical College
        • Contact:
      • Nanjing, China
        • Recruiting
        • Nanjing First Hospital, Nanjing Medical University
        • Contact:
      • Nanjing, China, 210029
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
      • Qingdao, China
        • Completed
        • The Affiliated Hospital of Qingdao University
      • Shanghai, China
        • Completed
        • Shanghai East Hospital Tongji University
      • Shantou, China
        • Recruiting
        • The First Affiliated Hospital of Shantou University Medical College
        • Contact:
      • Tianjin, China
        • Recruiting
        • Tianjin Chest Hospital
        • Contact:
      • Tianjin, China
        • Recruiting
        • TEDA International Cardiovascular Hospital
        • Contact:
      • Xiamen, China
        • Completed
        • Xiamen Cardiovascular Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Fuwai Hospital Chinese Academy of Medical Sciences
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Chongqing Hospital of Jiangsu Provincial People's Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
        • Sub-Investigator:
          • Xiao-yan Xiao-yan, MD
    • Guizhou
      • Xingyi, Guizhou, China
        • Recruiting
        • QianXiNan People's Hospital
        • Contact:
          • Yong Yao, MD
        • Sub-Investigator:
          • Shu-wen Wang, MD
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • The Second Affiliated Hospital of Harbin Medical University
        • Contact:
        • Sub-Investigator:
          • Peng-cheng Tang, MD
    • Jiangsu
      • Changzhou, Jiangsu, China
        • Recruiting
        • The Third Affiliated Hospital of Soochow University
        • Contact:
          • Chao Ma, MD
        • Contact:
      • Suqian, Jiangsu, China
        • Recruiting
        • Suqian Hospital of of Nanjing Medical University
        • Contact:
      • Yancheng, Jiangsu, China
        • Recruiting
        • Dongtai People'S Hospital
        • Contact:
          • Sheng-rong Lin, MD
        • Sub-Investigator:
          • Shengrong Lin, MD
      • Yangzhou, Jiangsu, China, 225001
        • Recruiting
        • Subei People's Hospital of Jiangsu province
        • Contact:
          • Cheng-bin Tang, MD
          • Phone Number: 051487373012
        • Principal Investigator:
          • Cheng-bin Tang, MD
    • Jiangxi
      • Nanchang, Jiangxi, China, 300088
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
          • Zhi-hua Zeng, MD
        • Contact:
        • Principal Investigator:
          • Zhi-hua Zeng, MD
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • QiLU Hospital of ShanDong University
        • Contact:
          • Xin Zhao, MD
          • Phone Number: 0531-82169114
        • Principal Investigator:
          • Xin Zhao, MD
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Shanghai DeltaHealth Hospital
        • Contact:
        • Sub-Investigator:
          • Li-zhong Sun, MD
    • Shanxi
      • Taiyuan, Shanxi, China
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
    • Xinjiang
      • Yining, Xinjiang, China
        • Recruiting
        • The Friendship Hospital of Yili Kazak Autonomous Prefecture
        • Contact:
      • Ürümqi, Xinjiang, China
        • Recruiting
        • The Seventh Affiliated Hospital of Xinjiang Medical University
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • The First Affiliated Hospital of Kunming Medical University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
        • Contact:
          • ZHIQIANG DONG, MD
      • Wenzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • ZHIWEI LI
        • Contact:
          • ZHIWEI LI, MA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Chinese patients suffering AAS

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative mortality
Time Frame: 30 days after treatment
Operative mortality was defined as any death, regardless of cause, occurring whether within 30 days after surgery in or out of the hospital or after 30 days during the same hospitalization subsequent to the operation.
30 days after treatment
Severe systemic inflammatory response syndrome (SIRS)
Time Frame: 7 days after treatment
SIRS was defined as the presence of at least 2 of the 4 age-specific criteria: temperature, heart rate, respiratory rate, and leukocyte count, one of which must be abnormal temperature or leukocyte count. severe SIRS was defined as meeting all 4 aforementioned criteria, measured immediately following surgery through postoperative day 7.
7 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Collaborators

Beijing Anzhen Hospital

Investigators

  • Study Director: Hong-jia Zhang, MD, Beijing Anzhen Hospital
  • Principal Investigator: Si-chong Qian, Beijing Anzhen Hospital
  • Principal Investigator: Hong Liu, Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 22, 2020

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5A-Plan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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