NCT04398992

Additive Anti-inflammatory Action for Aortopathy & Arteriopathy

Recruiting now Last updated 9 February 2026

What this trial tests

trial testing observation in Acute Aortic Syndrome in 10,000 participants. Currently enrolling.

Timeline

1 January 2016

Primary endpoint
31 December 2030

31 December 2030

Quick facts

Lead sponsor	Nanjing Medical University
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	10,000
Start date	1 January 2016
Primary completion	31 December 2030
Estimated completion	31 December 2030
Sites	34 locations across China

Drugs / interventions tested

• observation

Conditions studied

• Acute Aortic Syndrome — all drugs for Acute Aortic Syndrome →

Sponsor

Nanjing Medical University

Who can join

18 and older, any sex, with Acute Aortic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Inflammatory risk stratification individualizes anti-inflammatory pharmacotherapy for acute type A aortic dissection.
   Liu H, Li H, Han L, Zhang Y, et al · · 2023 · cited 20× · PMID 37333431 · DOI 10.1016/j.xinn.2023.100448
2. Inflammatory profiles define phenotypes with clinical relevance in acute type A aortic dissection.
   Zhao HL, Tang ZW, Diao YF, Xu XF, et al · · 2023 · cited 10× · PMID 37713048 · DOI 10.1007/s12265-023-10436-z
3. Prognostic implication of residual inflammatory trajectories in acute type I aortic dissection: dual-center prospective cohort study.
   Liu H, Diao YF, Shao YF, Qian SC, et al · · 2024 · cited 7× · PMID 38445499 · DOI 10.1097/js9.0000000000001245
4. Anti-inflammatory response-based risk assessment in acute type A aortic dissection: A national multicenter cohort study.
   Liu H, Sun BQ, Tang ZW, Qian SC, et al · · 2024 · cited 5× · PMID 38313452 · DOI 10.1016/j.ijcha.2024.101341
5. Inflammatory signature-based theranostics for acute lung injury in acute type A aortic dissection.
   Liu H, Diao YF, Qian SC, Shao YF, et al · · 2024 · cited 3× · PMID 39234501 · DOI 10.1093/pnasnexus/pgae371
6. Operative Mortality After Type A Aortic Dissection Surgery: Differences Based on Sex and Age.
   Liu H, Li HY, Li YL, Wu Y, et al · · 2024 · cited 3× · PMID 38939657 · DOI 10.1016/j.jacadv.2024.100909
7. Inflammatory Trajectory and Anti-Inflammatory Pharmacotherapy in Frozen Elephant Trunk-Treated Acute Type I Aortic Dissection.
   Liu H, Diao YF, Xu XF, Qian SC, et al · · 2024 · cited 2× · PMID 39132007 · DOI 10.1016/j.jscai.2024.101935
8. Chinese Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Registry protocol: rationale, design and methodology.
   Liu H, Qian SC, Li HY, Shao YF, et al · · 2024 · cited 2× · PMID 38383323 · DOI 10.1186/s12872-024-03760-y