Additive Anti-inflammatory Action for Aortopathy & Arteriopathy
Chinese Registry of Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Protocol: Rationale, Design and Methodology
Nanjing Medical University
10,000 participants
Jan 1, 2016
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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;
Exclusion Criteria4
- 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.
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Interventions
Data were collected by a designed form. Statistic software was used to analyze clinical data.
Locations(34)
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NCT04398992