Acute Aortic SyndromeNCT04398992
Additive Anti-inflammatory Action for Aortopathy & Arteriopathy
An observational study of Acute Aortic Syndrome, run by Nanjing Medical University at 34 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Aortic Syndrome
- What is being tested?
- observation
- How many people
- 10,000 participants
- Where
- 34 sitesChina
- Study dates
- 1 Jan 2016to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese patients suffering AAS
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
34 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hai-yang LI, MD contact
34 sites in 1 country
China34 sites, 30 recruiting
- Recruiting
Beijing Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Hongwei Guo, MD, ghwdr@sina.com
- Recruiting
Beijing Anzhen Hospital Capital Medical University
Beijing
Si-chong Qian, 13120130755, drqsc1990a@163.com
- Recruiting
Beijing Chaoyang Hospital
Beijing
Lu Han, MD
Lu Han, MD, moer031@163.com
- Recruiting
the First Affiliated Hospital of Bengbu Medical College
Bengbu
Yi-yao Jiang, MD, jiangyiyao0309@sina.com
- Completed
Xiangya Hospital Central South University
Changsha
- Recruiting
The Third Affiliated Hospital of Soochow University
Changzhou, Jiangsu
Chao ma, MD, machaomain@163.com
Chao Ma, MD
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Hong-hua Yue, 13281130798, yuecqmu@163.com
- Recruiting
Chongqing Hospital of Jiangsu Provincial People's Hospital
Chongqing, Chongqing Municipality
Xiao-tong Qi, MD, xtqi01@njmu.edu.cn
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Xiao-kang Luo, 02083882222, luoxkang@gmail.com
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Ying-yuan Zhang, MD, 13662378847@139.com
- Recruiting
the First Affiliated Hospital of Guilin Medical College
Guilin
Xing-xing Peng, MD, 317018918@qq.com
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
ZHIQIANG Dong, MD, namedzq@foxmail.com
ZHIQIANG DONG, MD
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Peng-cheng Tang, MD, 17581862412@163.com
Peng-cheng Tang, MD
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Xin Zhao, MD, 0531-82169114
Xin Zhao, MD
- Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Xiang-feng Bai, 8715324888, 49976790@qq.com
- Recruiting
the Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 300088
Zhi-hua Zeng, MD
Zhi-hua Zeng, MD, 284569879@qq.com
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, 210029
Hong Liu, MD, 188012181613, dr.hongliu@foxmail.com
- Recruiting
Nanjing First Hospital, Nanjing Medical University
Nanjing
Liang Hong, MD, hong3031@163.com
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Xiao-yan Feng, MD, fengxy0225@163.com
Xiao-yan Xiao-yan, MD
- Completed
the Affiliated Hospital of Qingdao University
Qingdao
- Recruiting
Shanghai DeltaHealth Hospital
Shanghai, Shanghai Municipality
Li-zhong Sun, MD, 17314457623, lzsuncmu@sina.com
Li-zhong Sun, MD
- Completed
Shanghai East Hospital Tongji University
Shanghai
- Recruiting
the First Affiliated Hospital of Shantou University Medical College
Shantou
Ying Wu, MD, 13531150081@163.com
- Recruiting
Suqian Hospital of of Nanjing Medical University
Suqian, Jiangsu
Xiang Liu, MD, liuxiang@njmu.edu.cn
- Recruiting
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi
Yi-fan Li, MD, liyifanjuven@outlook.com
- Recruiting
Teda International Cardiovascular Hospital
Tianjin
Yu-qi Wang, MD, wyq530.ok@163.com
- Recruiting
Tianjin Chest Hospital
Tianjin
JUN-QUAN CHEN, MD, 644765651@qq.com
- Recruiting
The Seventh Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Xu-ran Lu, 09914609084, luxuran8@live.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
ZHIWEI LI
ZHIWEI LI, MA
- Completed
Xiamen Cardiovascular Hospital
Xiamen
- Recruiting
QianXiNan People's Hospital
Xingyi, Guizhou
Yong Yao, MD
Shu-wen Wang, MD
- Recruiting
Dongtai People's Hospital
Yancheng, Jiangsu
Sheng-rong Lin, MD
Shengrong Lin, MD
- Recruiting
Subei People's Hospital of Jiangsu Province
Yangzhou, Jiangsu, 225001
Cheng-bin Tang, MD, 051487373012
Cheng-bin Tang, MD
- Recruiting
The Friendship Hospital of Yili Kazak Autonomous Prefecture
Yining, Xinjiang
Xiang-xiang Zheng, MD, 8613851799076, 67322914@qq.com
About this study
Official title: Chinese Registry of Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Protocol: Rationale, Design and Methodology
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.
Read the 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.
- Conditions
- Acute Aortic Syndrome
- Being tested
- observation
- Keywords
- Acute Aortic Syndrome
- Medical subject headings
- Acute Aortic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
Data were collected by a designed form. Statistic software was used to analyze clinical data.
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative mortality
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.
Measured: 30 days after treatment
Severe systemic inflammatory response syndrome (SIRS)
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.
Measured: 7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Jan 2016
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Aortic SyndromeStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital
- Responsible party
- Principal investigator, Hong Liu, Nanjing Medical University
- Investigators
- Hong-jia Zhang, MD, Study director, Beijing Anzhen HospitalHong Liu, Principal investigator, Nanjing Medical UniversitySi-chong Qian, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398992
- Sponsor's protocol ID
- 5A-Plan
- Status last verified
- Feb 2026
- First submitted
- 19 May 2020
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu H, Li HY, Li YL, Wu Y, Gu JX, Diao YF, Shao YF, Sun LZ, Qian SC, Zhang HJ; 5A Investigators. Operative Mortality After Type A Aortic Dissection Surgery: Differences Based on Sex and Age. JACC Adv. 2024 Mar 14;3(4):100909. doi: 10.1016/j.jacadv.2024.100909. eCollection 2024 Apr.
PubMed 38939657Liu H, Diao YF, Shao YF, Qian SC, Zeng ZH, Fan GL, Ma LY, Zhang HJ; on the behalf of the Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Investigators. Prognostic implication of residual inflammatory trajectories in acute type I aortic dissection: dual-center prospective cohort study. Int J Surg. 2024 Jun 1;110(6):3346-3356. doi: 10.1097/JS9.0000000000001245.
PubMed 38445499Liu H, Qian SC, Li HY, Shao YF, Zhang HJ; China Additive Anti-inflammatory Action for Aortopathy, Arteriopathy (5A) Investigators. Chinese Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Registry protocol: rationale, design and methodology. BMC Cardiovasc Disord. 2024 Feb 21;24(1):120. doi: 10.1186/s12872-024-03760-y.
PubMed 38383323Liu H, Sun BQ, Qian SC, Sun MY, Shao YF, Ding Y, Li H, Zhang HJ. Contemporary use and outcome of Cabrol shunt in type A aortic dissection surgery: insight from China 5A study. Open Heart. 2023 Dec 9;10(2):e002465. doi: 10.1136/openhrt-2023-002465.
PubMed 38070883Zhao HL, Tang ZW, Diao YF, Xu XF, Qian SC, Li HY, Shao YF, Zhao S, Liu H; on the behalf of the Additive Anti-inflammatory Action for Aortopathy, Arteriopathy (5A) Investigators. Inflammatory profiles define phenotypes with clinical relevance in acute type A aortic dissection. J Cardiovasc Transl Res. 2023 Dec;16(6):1383-1391. doi: 10.1007/s12265-023-10436-z. Epub 2023 Sep 15.
PubMed 37713048
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Registry of Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Protocol: Rationale, Design and Methodology
- ClinicalTrials.gov ID
- NCT04398992
- Acronym / sponsor ID
- 5A-Plan
- Conditions
- Acute Aortic Syndrome
- Keywords
- Acute Aortic Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese patients suffering AAS
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationData were collected by a designed form. Statistic software was used to analyze clinical data. | Other | – |
Primary outcome
Operative mortality
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Derived from this study: PubMed 38939657Liu H, Li HY, Li YL, Wu Y, Gu JX, Diao YF, Shao YF, Sun LZ, Qian SC, Zhang HJ; 5A Investigators. Operative Mortality After Type A Aortic Dissection Surgery: Differences Based on Sex and Age. JACC Adv. 2024 Mar 14;3(4):100909. doi: 10.1016/j.jacadv.2024.100909. eCollection 2024 Apr.
- Derived from this study: PubMed 38445499Liu H, Diao YF, Shao YF, Qian SC, Zeng ZH, Fan GL, Ma LY, Zhang HJ; on the behalf of the Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Investigators. Prognostic implication of residual inflammatory trajectories in acute type I aortic dissection: dual-center prospective cohort study. Int J Surg. 2024 Jun 1;110(6):3346-3356. doi: 10.1097/JS9.0000000000001245.
- Derived from this study: PubMed 38383323Liu H, Qian SC, Li HY, Shao YF, Zhang HJ; China Additive Anti-inflammatory Action for Aortopathy, Arteriopathy (5A) Investigators. Chinese Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Registry protocol: rationale, design and methodology. BMC Cardiovasc Disord. 2024 Feb 21;24(1):120. doi: 10.1186/s12872-024-03760-y.
- Derived from this study: PubMed 38070883Liu H, Sun BQ, Qian SC, Sun MY, Shao YF, Ding Y, Li H, Zhang HJ. Contemporary use and outcome of Cabrol shunt in type A aortic dissection surgery: insight from China 5A study. Open Heart. 2023 Dec 9;10(2):e002465. doi: 10.1136/openhrt-2023-002465.
- Derived from this study: PubMed 37713048Zhao HL, Tang ZW, Diao YF, Xu XF, Qian SC, Li HY, Shao YF, Zhao S, Liu H; on the behalf of the Additive Anti-inflammatory Action for Aortopathy, Arteriopathy (5A) Investigators. Inflammatory profiles define phenotypes with clinical relevance in acute type A aortic dissection. J Cardiovasc Transl Res. 2023 Dec;16(6):1383-1391. doi: 10.1007/s12265-023-10436-z. Epub 2023 Sep 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hai-yang LI, MD contact
Hong-jia Zhang, MD study director
Beijing Anzhen Hospital
Hong Liu principal investigator
Nanjing Medical University
Si-chong Qian principal investigator
Beijing Anzhen Hospital
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Aortic Syndrome, run by Nanjing Medical University at 34 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Liu, MD (02568303100, DR.HONGLIU@FOXMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative mortality (time frame: 30 days after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04398992, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.