Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04398992 |
| Other study ID # |
5A-Plan |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2016 |
| Est. completion date |
December 31, 2040 |
Study information
| Verified date |
November 2023 |
| Source |
Nanjing Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
