Perioperative Eosinophils Their Recovery in Type A Acute Aortic Dissection Prognosis

NCT ID: NCT05409677

Last Updated: 2022-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

274 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-06-07

Brief Summary

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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.

Detailed Description

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For this study, 274 patients with TA-AAD admitted into our hospital between February 2019 and July 2021 were enrolled retrospectively. A total of 54 patients deceased unfortunately within 1 month following surgery. We compared baseline sociodemographic, clinical, and functional status based on the main outcome using t tests or Mann-Whitney U test for continuous data and χ2 or Fisher's exact tests for categorical data. Continuous variables were expressed as mean SD median depending on the normality of distribution, and categorical variables were expressed as absolute number along with their percentages and compared using the chi-square test. Multivariate regression analysis was applied to assess the association between EOS and 1-month mortality in an unadjusted model, in an age-, sex-, Body mass index (BMI)-adjusted model (model 2), adjusted for age, sex, BMI, systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) (model 3), and further adjusting for age, sex, BMI, SBP, DBP, MAP, heart rate (HR), diabetes, stroke and hyperlipidemia (model 4). In addition, the general linear model repeated-measures ANOVA analysis (Corrected by Greenhouse-Geisser test in nonspherical cases) was used to compare preoperative EOS and postoperative eight-days EOS. For prognostic analysis, receiver-operating characteristics (ROC) curves were used to determine the optimal cutoff of EOS at different points and the time of postoperative EOS to return to normal levels for the prognostic events. A Kaplan-Meier curve was then applied to compare the prognosis between the 2 subgroups based on the predictive threshold. A P value\<0.05 was regarded as statistically significant for all statistical tests.

Conditions

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Acute Aortic Dissection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

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

Intervention Type OTHER

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

Interventions

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

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yang Yan, Doctor

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Locations

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First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, China

Site Status

First Affiliated Hospital of Xiann JiaotongUniversity

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 38622370 (View on PubMed)

Other Identifiers

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81871607

Identifier Type: -

Identifier Source: org_study_id

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