Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (Multicenter Cohort Study) III

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.

Study Overview

• Status: Completed
• Conditions: Aortic Dissection
• Intervention / Treatment: Biological: inflammatory response

• Study Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• acute type Aortic dissection;

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
inflammatory subphenotype	Biological: inflammatory response; laboratory data (leukocyte, neutrophils, monocyte, lymphocytes, platelet, fibrinogen, D-dimer, neutrophils-lymphocyte ratio, platelet-lymphocyte ratio, lymphocyte-monocyte ratio)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality	any cause death within 30 days of surgery	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU mortality	any cause death within ICU	7 days after surgery

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Xiangya Hospital of Central South University; The Affiliated Hospital of Qingdao University; Nanjing First Hospital, Nanjing Medical University; Beijing Anzhen Hospital; The First Affiliated Hospital of Guangzhou Medical University; First Affiliated Hospital Bengbu Medical College; The First Affiliated Hospital of Shantou University Medical College; TEDA International Cardiovascular Hospital; Xiamen Cardiovascular Hospital; Shanghai East Hospital Tongji University; Tianjin Chest Hospital, Tianjin Medical University

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Mayo Clin Proc Innov Qual Outcomes. 2024 Sep 16;8(5):481. doi: 10.1016/j.mayocpiqo.2024.08.002.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 17, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Inflammatory Response; Aortic Dissection
• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection
• Other Study ID Numbers: 5A Plan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No