Aortic DissectionNCT04918108
Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (Multicenter Cohort Study) III
An observational study of Aortic Dissection, run by Nanjing Medical University at 1 site in China.
Trial summary
Anatomopathological classifications have been well identified in aortic dissection with important therapeutic implications. The authors evaluated the inflammatory response in patients with aortic dissection (AD) and assessed the presence of distinct inflammatory subphenotypes within this disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- inflammatory response
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent venipuncture during primary evaluation in the Emergency Department. Venous blood samples were immediately sent to the laboratory for analysis.
Who may be able to join
- acute type Aortic dissection;
Who cannot join
- Iatrogenic aortic dissection OR traumatic aortic dissection
- Patients with hematological diseases, infectious diseases, malignant tumors, immune system diseases, or severe liver diseases.
- Preoperative use of mechanical ventilation, blood transfusion, renal replacement therapy, extracorporeal membrane oxygenation, or intra-aortic balloon pump during the current admission.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of nanjing medical university
Nanjing, Jiangsu, 210029
About this study
Official title: Inflammatory Response and Anti-inflammatory Action for Aortopathy & Arteriopathy (5A-Plan): A Multicenter Cohort Study
Anatomopathological classifications have been well identified in aortic dissection with important therapeutic implications. The authors evaluated the inflammatory response in patients with aortic dissection (AD) and assessed the presence of distinct inflammatory subphenotypes within this disease.
- Conditions
- Aortic Dissection
- Being tested
- inflammatory response
- Keywords
- Aortic Dissection, Inflammatory Response
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inflammatory responseBiological
laboratory data (leukocyte, neutrophils, monocyte, lymphocytes, platelet, fibrinogen, D-dimer, neutrophils-lymphocyte ratio, platelet-lymphocyte ratio, lymphocyte-monocyte ratio)
| Study group | Role | What they receive |
|---|---|---|
| inflammatory subphenotype | Not described Receives: Biological: inflammatory response |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
any cause death within 30 days of surgery
Measured: 30 days after surgery
Secondary outcomes (1)
ICU mortality
any cause death within ICU
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start1 Jan 2021
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
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 Aortic DissectionStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Beijing Anzhen Hospital, The Affiliated Hospital of Qingdao University, First Affiliated Hospital of Shantou University Medical College, The First Affiliated Hospital of Guangzhou Medical University, TEDA International Cardiovascular Hospital, Xiamen Cardiovascular Hospital, Shanghai East Hospital of Tongji University, Tianjin Chest Hospital, Nanjing First Hospital, Nanjing Medical University, Xiangya Hospital of Central South University, The First Affiliated Hospital of Bengbu Medical University
- Responsible party
- Principal investigator, Hong Liu, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918108
- Sponsor's protocol ID
- 5A Plan
- Status last verified
- Nov 2024
- First submitted
- 3 Jun 2021
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu H, Zhang YY, Ding XH, Qian SC, Sun MY, Hamzah AW, Gao YN, Shao YF, Li HY, Wang K, Ni BQ, Zhang HJ; Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Investigators. Proximal vs Extensive Repair in Acute Type A Aortic Dissection Surgery. Ann Thorac Surg. 2023 Aug;116(2):270-278. doi: 10.1016/j.athoracsur.2023.04.019. Epub 2023 Apr 25.
PubMed 37105511Liu H, Qian SC, Shao YF, Li HY, Zhang HJ; 5A Investigators. Prognostic Impact of Systemic Coagulation-Inflammation Index in Acute Type A Aortic Dissection Surgery. JACC Asia. 2022 Oct 4;2(6):763-776. doi: 10.1016/j.jacasi.2022.06.007. eCollection 2022 Nov.
PubMed 36444319Liu H, Qian SC, Han L, Dong ZQ, Shao YF, Li HY, Zhang W, Zhang HJ. Laboratory signatures differentiate the tolerance to hypothermic circulatory arrest in acute type A aortic dissection surgery. Interact Cardiovasc Thorac Surg. 2022 Nov 8;35(6):ivac267. doi: 10.1093/icvts/ivac267.
PubMed 36271847Liu H, Qian SC, Zhang YY, Wu Y, Hong L, Yang JN, Zhong JS, Wang YQ, Wu DK, Fan GL, Chen JQ, Zhang SQ, Peng XX, Shao YF, Li HY, Zhang HJ. A Novel Inflammation-Based Risk Score Predicts Mortality in Acute Type A Aortic Dissection Surgery: The Additive Anti-inflammatory Action for Aortopathy and Arteriopathy Score. Mayo Clin Proc Innov Qual Outcomes. 2022 Sep 25;6(6):497-510. doi: 10.1016/j.mayocpiqo.2022.08.005. eCollection 2022 Dec.
PubMed 36185465Liu H, Qian SC, Shao YF, Li HY; Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Investigators Group. Anti-Inflammatory Effect of Ulinastatin on the Association Between Inflammatory Phenotypes in Acute Type A Aortic Dissection. J Inflamm Res. 2022 Jun 27;15:3709-3718. doi: 10.2147/JIR.S369703. eCollection 2022.
PubMed 35783246
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Response and Anti-inflammatory Action for Aortopathy & Arteriopathy (5A-Plan): A Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT04918108
- Acronym / sponsor ID
- 5A Plan
- Conditions
- Aortic Dissection
- Keywords
- Aortic Dissection, Inflammatory Response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Beijing Anzhen Hospital, The Affiliated Hospital of Qingdao University, First Affiliated Hospital of Shantou University Medical College, The First Affiliated Hospital of Guangzhou Medical University, TEDA International Cardiovascular Hospital, Xiamen Cardiovascular Hospital, Shanghai East Hospital of Tongji University, Tianjin Chest Hospital, Nanjing First Hospital, Nanjing Medical University, Xiangya Hospital of Central South University, The First Affiliated Hospital of Bengbu Medical University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 8 Jun 2021 (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.
Anatomopathological classifications have been well identified in aortic dissection with important therapeutic implications. The authors evaluated the inflammatory response in patients with aortic dissection (AD) and assessed the presence of distinct inflammatory subphenotypes within this disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inflammatory subphenotype | – | Biological: inflammatory response |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent venipuncture during primary evaluation in the Emergency Department. Venous blood samples were immediately sent to the laboratory for analysis.
Key inclusion criteria (1 listed)
- acute type Aortic dissection;
Key exclusion criteria (3 listed)
- Iatrogenic aortic dissection OR traumatic aortic dissection
- Patients with hematological diseases, infectious diseases, malignant tumors, immune system diseases, or severe liver diseases.
- Preoperative use of mechanical ventilation, blood transfusion, renal replacement therapy, extracorporeal membrane oxygenation, or intra-aortic balloon pump during the current admission.
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 |
|---|---|---|
| inflammatory responselaboratory data (leukocyte, neutrophils, monocyte, lymphocytes, platelet, fibrinogen, D-dimer, neutrophils-lymphocyte ratio, platelet-lymphocyte ratio, lymphocyte-monocyte ratio) | Biological | inflammatory subphenotype |
Primary outcome
30-day mortality
Time frame: 30 days after surgery
any cause death within 30 days of surgery
1 secondary outcome
ICU mortality
Time frame: 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Derived from this study: PubMed 37105511Liu H, Zhang YY, Ding XH, Qian SC, Sun MY, Hamzah AW, Gao YN, Shao YF, Li HY, Wang K, Ni BQ, Zhang HJ; Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Investigators. Proximal vs Extensive Repair in Acute Type A Aortic Dissection Surgery. Ann Thorac Surg. 2023 Aug;116(2):270-278. doi: 10.1016/j.athoracsur.2023.04.019. Epub 2023 Apr 25.
- Derived from this study: PubMed 36444319Liu H, Qian SC, Shao YF, Li HY, Zhang HJ; 5A Investigators. Prognostic Impact of Systemic Coagulation-Inflammation Index in Acute Type A Aortic Dissection Surgery. JACC Asia. 2022 Oct 4;2(6):763-776. doi: 10.1016/j.jacasi.2022.06.007. eCollection 2022 Nov.
- Derived from this study: PubMed 36271847Liu H, Qian SC, Han L, Dong ZQ, Shao YF, Li HY, Zhang W, Zhang HJ. Laboratory signatures differentiate the tolerance to hypothermic circulatory arrest in acute type A aortic dissection surgery. Interact Cardiovasc Thorac Surg. 2022 Nov 8;35(6):ivac267. doi: 10.1093/icvts/ivac267.
- Derived from this study: PubMed 36185465Liu H, Qian SC, Zhang YY, Wu Y, Hong L, Yang JN, Zhong JS, Wang YQ, Wu DK, Fan GL, Chen JQ, Zhang SQ, Peng XX, Shao YF, Li HY, Zhang HJ. A Novel Inflammation-Based Risk Score Predicts Mortality in Acute Type A Aortic Dissection Surgery: The Additive Anti-inflammatory Action for Aortopathy and Arteriopathy Score. Mayo Clin Proc Innov Qual Outcomes. 2022 Sep 25;6(6):497-510. doi: 10.1016/j.mayocpiqo.2022.08.005. eCollection 2022 Dec.
- Derived from this study: PubMed 35783246Liu H, Qian SC, Shao YF, Li HY; Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Investigators Group. Anti-Inflammatory Effect of Ulinastatin on the Association Between Inflammatory Phenotypes in Acute Type A Aortic Dissection. J Inflamm Res. 2022 Jun 27;15:3709-3718. doi: 10.2147/JIR.S369703. eCollection 2022.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection, run by Nanjing Medical University at 1 site 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: 30 days after surgery). 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 NCT04918108, 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 20 Nov 2024.