NCT05409677

Brief Summary

Type A acute aortic dissection (TA-AAD) patients are prone to life-threatening complications and death during the acute phase. Currently, little evidence is available with regards to the relationship between eosinophils (EOS) and TA-AAD. A total of 274 patients with TA-AAD were eligible for inclusion and 54 patients deceased within 1 month following surgery. Multivariate regression analysis, the general linear model repeated-measures ANOVA analysis (corrected by Greenhouse-Geisser test), receiver-operating characteristics (ROC) curves and a Kaplan-Meier curve were applied for statistical analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
274

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

February 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
Last Updated

June 8, 2022

Status Verified

May 1, 2022

Enrollment Period

2.2 years

First QC Date

May 25, 2022

Last Update Submit

June 5, 2022

Conditions

Keywords

Type A acute aortic dissection; Eosinophils; Prognosis

Outcome Measures

Primary Outcomes (1)

  • mortality

    The primary outcome was 1-month mortality

    The first month after operation

Secondary Outcomes (1)

  • Infection and in-hospital poor prognosis

    An average of 1 year

Study Arms (1)

1-month survivors; 1-month non-survivors

Depending on mortality within 1 month, the patients were divided into two groups named 1-month survivors and 1-month non-survivors.There was no intervention other than normal treatment

Other: This was a retrospective study with no intervention other than normal treatment

Interventions

This was a retrospective study with no intervention other than normal treatment

1-month survivors; 1-month non-survivors

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients were dignosed with Type A acute aortic dissection by the computer tomography between February 2019 and July 2021. A total of 54 patients deceased unfortunately within 1 month following surgery. Depending on mortality within 1 month, the baseline characteristics was compared. Patients were 51.58±11.57 years of age, 203(74.1%) men, and 161(58.8%) with hypertension. There was no discernible difference in gender, BMI, smoking, and alcohol consumption (P\>0.05). Moreover, in addition to renal insufficiency, medical histories showed no remarkable deviations between the aforementioned two groups. Non-survivors within 1 month were more likely to have renal insufficiency (6.8% vs. 20.4%; P=0.005).

You may qualify if:

  • The patients with a diagnosis of Type A acute aortic dissection by the computer tomography

You may not qualify if:

  • History of cardiogenic shock or cardiac tamponade;
  • Iatrogenic aortic dissection;
  • Traumatic aortic dissection;
  • Severe valvular disease;
  • Congenital heart disease;
  • Severe organ dysfunction, such as liver and kidney failure;
  • Metabolic diseases such as gout or hyperthyroidism;
  • Malignant tumor;
  • Severe gastrointestinal diseases;
  • Recent drug usage that might affect EOS;
  • Allergic diseases;
  • Infectious diseases;
  • Skin diseases;
  • Hematological diseases, such as leukemia and myelodysplastic syndromes;
  • Immune system diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, 710061, China

Location

First Affiliated Hospital of Xiann JiaotongUniversity

Xi'an, Shaanxi, 710061, China

Location

Related Publications (1)

  • Wang X, Zhu Y, Ma X, Ren J, Yan Y, Liu Y, Gao H, Zhang S, Chen Y, Yang Y, Deng C. Eosinophil Recovery Time Is Associated with Clinical Outcomes in Patients with Type A Acute Aortic Dissection: a Retrospective Cohort Study. J Cardiovasc Transl Res. 2024 Jun;17(3):723-731. doi: 10.1007/s12265-023-10468-5. Epub 2024 Apr 15.

Study Officials

  • Yang Yan, Doctor

    First Affiliated Hospital Xi'an Jiaotong University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

June 8, 2022

Study Start

February 1, 2019

Primary Completion

April 6, 2021

Study Completion

June 7, 2021

Last Updated

June 8, 2022

Record last verified: 2022-05

Locations