Additive Anti-inflammatory Action for Aortopathy & Arteriopathy
Chinese Registry of Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Protocol: Rationale, Design and Methodology
1 other identifier
observational
10,000
1 country
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
Longer than P75 for all trials
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 19, 2020
CompletedFirst Posted
Study publicly available on registry
May 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
February 9, 2026
February 1, 2026
15 years
May 19, 2020
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Operative mortality
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)
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
Interventions
Data were collected by a designed form. Statistic software was used to analyze clinical data.
Eligibility Criteria
Chinese patients suffering AAS
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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanjing Medical Universitylead
- Beijing Anzhen Hospitalcollaborator
Study Sites (34)
Beijing Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Chongqing Hospital of Jiangsu Provincial People's Hospital
Chongqing, Chongqing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
QianXiNan People's Hospital
Xingyi, Guizhou, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Third Affiliated Hospital of Soochow University
Changzhou, Jiangsu, China
Suqian Hospital of of Nanjing Medical University
Suqian, Jiangsu, China
Dongtai People's Hospital
Yancheng, Jiangsu, China
Subei People's Hospital of Jiangsu Province
Yangzhou, Jiangsu, 225001, China
the Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 300088, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Shanghai DeltaHealth Hospital
Shanghai, Shanghai Municipality, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
The Seventh Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The Friendship Hospital of Yili Kazak Autonomous Prefecture
Yining, Xinjiang, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Beijing Anzhen Hospital Capital Medical University
Beijing, China
Beijing Chaoyang Hospital
Beijing, China
the First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Xiangya Hospital Central South University
Changsha, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
the First Affiliated Hospital of Guilin Medical College
Guilin, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, 210029, China
Nanjing First Hospital, Nanjing Medical University
Nanjing, China
the Affiliated Hospital of Qingdao University
Qingdao, China
Shanghai East Hospital Tongji University
Shanghai, China
the First Affiliated Hospital of Shantou University Medical College
Shantou, China
Teda International Cardiovascular Hospital
Tianjin, China
Tianjin Chest Hospital
Tianjin, China
Xiamen Cardiovascular Hospital
Xiamen, China
Related Publications (5)
Liu H, Li HY, Li YL, Wu Y, Gu JX, Diao YF, Shao YF, Sun LZ, Qian SC, Zhang HJ; 5A Investigators. Operative Mortality After Type A Aortic Dissection Surgery: Differences Based on Sex and Age. JACC Adv. 2024 Mar 14;3(4):100909. doi: 10.1016/j.jacadv.2024.100909. eCollection 2024 Apr.
PMID: 38939657DERIVEDLiu H, Diao YF, Shao YF, Qian SC, Zeng ZH, Fan GL, Ma LY, Zhang HJ; on the behalf of the Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Investigators. Prognostic implication of residual inflammatory trajectories in acute type I aortic dissection: dual-center prospective cohort study. Int J Surg. 2024 Jun 1;110(6):3346-3356. doi: 10.1097/JS9.0000000000001245.
PMID: 38445499DERIVEDLiu H, Qian SC, Li HY, Shao YF, Zhang HJ; China Additive Anti-inflammatory Action for Aortopathy, Arteriopathy (5A) Investigators. Chinese Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Registry protocol: rationale, design and methodology. BMC Cardiovasc Disord. 2024 Feb 21;24(1):120. doi: 10.1186/s12872-024-03760-y.
PMID: 38383323DERIVEDLiu H, Sun BQ, Qian SC, Sun MY, Shao YF, Ding Y, Li H, Zhang HJ. Contemporary use and outcome of Cabrol shunt in type A aortic dissection surgery: insight from China 5A study. Open Heart. 2023 Dec 9;10(2):e002465. doi: 10.1136/openhrt-2023-002465.
PMID: 38070883DERIVEDZhao HL, Tang ZW, Diao YF, Xu XF, Qian SC, Li HY, Shao YF, Zhao S, Liu H; on the behalf of the Additive Anti-inflammatory Action for Aortopathy, Arteriopathy (5A) Investigators. Inflammatory profiles define phenotypes with clinical relevance in acute type A aortic dissection. J Cardiovasc Transl Res. 2023 Dec;16(6):1383-1391. doi: 10.1007/s12265-023-10436-z. Epub 2023 Sep 15.
PMID: 37713048DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hong-jia Zhang, MD
Beijing Anzhen Hospital
- PRINCIPAL INVESTIGATOR
Hong Liu
Nanjing Medical University
- PRINCIPAL INVESTIGATOR
Si-chong Qian
Beijing Anzhen Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator of Department of Cardiac Surgery
Study Record Dates
First Submitted
May 19, 2020
First Posted
May 22, 2020
Study Start
January 1, 2016
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
February 9, 2026
Record last verified: 2026-02