NCT04918108

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

June 3, 2021

Last Update Submit

November 17, 2024

Conditions

Keywords

Aortic DissectionInflammatory Response

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    any cause death within 30 days of surgery

    30 days after surgery

Secondary Outcomes (1)

  • ICU mortality

    7 days after surgery

Study Arms (1)

inflammatory subphenotype

Biological: inflammatory response

Interventions

laboratory data (leukocyte, neutrophils, monocyte, lymphocytes, platelet, fibrinogen, D-dimer, neutrophils-lymphocyte ratio, platelet-lymphocyte ratio, lymphocyte-monocyte ratio)

inflammatory subphenotype

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients underwent venipuncture during primary evaluation in the Emergency Department. Venous blood samples were immediately sent to the laboratory for analysis.

You may qualify if:

  • acute type Aortic dissection;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital of nanjing medical university

Nanjing, Jiangsu, 210029, China

Location

Related Publications (5)

  • 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.

  • Liu 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.

  • Liu 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.

  • Liu 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.

  • Liu 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.

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator of Nanjing Medical University

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 8, 2021

Study Start

January 1, 2021

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

November 20, 2024

Record last verified: 2024-11

Locations