Additive Anti-inflammatory Action for Aortopathy & Arteriopathy
- Conditions
- Acute Aortic Syndrome
- Registration Number
- NCT04398992
- Lead Sponsor
- Nanjing Medical University
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 10000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Operative mortality 30 days after treatment 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.
Severe systemic inflammatory response syndrome (SIRS) 7 days after treatment 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Qilu Hospital of Shandong University
π¨π³Jinan, Shandong, China
Shanghai DeltaHealth Hospital
π¨π³Shanghai, Shanghai, China
Beijing Chaoyang Hospital
π¨π³Beijing, China
the First Affiliated Hospital of Bengbu Medical College
π¨π³Bengbu, China
Xiangya Hospital Central South University
π¨π³Changsha, China
the First Affiliated Hospital of Guilin Medical College
π¨π³Guilin, China
The First Affiliated Hospital of Nanjing Medical University
π¨π³Nanjing, China
Nanjing First Hospital, Nanjing Medical University
π¨π³Nanjing, China
the Affiliated Hospital of Qingdao University
π¨π³Qingdao, China
the First Affiliated Hospital of Shantou University Medical College
π¨π³Shantou, China
Teda International Cardiovascular Hospital
π¨π³Tianjin, China
Tianjin Chest Hospital
π¨π³Tianjin, China
Xiamen Cardiovascular Hospital
π¨π³Xiamen, China
Beijing Fuwai Hospital Chinese Academy of Medical Sciences
π¨π³Beijing, Beijing, China
Chongqing Hospital of Jiangsu Provincial People's Hospital
π¨π³Chongqing, Chongqing, China
Guangdong Provincial People's Hospital
π¨π³Guangzhou, Guangdong, China
Suqian Hospital of of Nanjing Medical University
π¨π³Suqian, Jiangsu, China
Shanxi Cardiovascular Hospital
π¨π³Taiyuan, Shanxi, China
West China Hospital of Sichuan University
π¨π³Chengdu, Sichuan, China
The Friendship Hospital of Yili Kazak Autonomous Prefecture
π¨π³Kazak, Xinjiang, China
The Seventh Affiliated Hospital of Xinjiang Medical University
π¨π³Urumchi, Xinjiang, China
The First Affiliated Hospital of Kunming Medical University
π¨π³Kunming, Yunnan, China
Beijing Anzhen Hospital Capital Medical University
π¨π³Beijing, China
The First Affiliated Hospital of Guangzhou Medical University
π¨π³Guangzhou, China
Shanghai East Hospital Tongji University
π¨π³Shanghai, China
The First Affiliated Hospital of Guangxi Medical University
π¨π³Nanning, Guangxi, China
The Second Affiliated Hospital of Harbin Medical University
π¨π³Harbin, Heilongjiang, China
Subei People's Hospital of Jiangsu Province
π¨π³Yangzhou, Jiangsu, China
the Second Affiliated Hospital of Nanchang University
π¨π³Nanchang, Jiangxi, China