Additive Anti-inflammatory Action for Aortopathy & Arteriopathy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNanjing Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • observation

Treatment groups

No treatment groups listed

Sponsors and collaborators

Nanjing Medical University

Lead sponsor

Beijing Anzhen Hospital

Collaborator