NCT04398992 Additive Anti-inflammatory Action for Aortopathy & Arteriopathy
| NCT ID | NCT04398992 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanjing Medical University |
| Condition | Acute Aortic Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2016-01-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2016-01-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion criteria * 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; * The patient or guardian agrees to participate in this study. Exclusion criteria * 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.
Contact & Investigator
Hong-jia Zhang, MD
STUDY DIRECTOR
Beijing Anzhen Hospital
Frequently Asked Questions
Who can join the NCT04398992 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Aortic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04398992 currently recruiting?
Yes, NCT04398992 is actively recruiting participants. Contact the research team at DR.HONGLIU@FOXMAIL.COM for enrollment information.
Where is the NCT04398992 trial being conducted?
This trial is being conducted at Beijing, China, Chongqing, China, Guangzhou, China, Nanning, China and 11 additional locations.
Who is sponsoring the NCT04398992 clinical trial?
NCT04398992 is sponsored by Nanjing Medical University. The principal investigator is Hong-jia Zhang, MD at Beijing Anzhen Hospital. The trial plans to enroll 10,000 participants.