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临床试验/NCT07489313
NCT07489313已完成不适用

Association of Prosthesis Types for Aortic or Mitral Valve Replacement With Long-term Risk of Mental Disorders

Samsung Medical Center0 个研究点目标入组 1,811 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,811
主要终点
Incident mental disorder after valve replacement

研究概览

简要总结

Patients were enrolled if the patients aged 60 to 70 years who underwent surgical aortic or mitral valve replacement. The age range was restricted to 60 to 70 years to ensure comparability in surgical indications between prosthesis types. Patients who underwent concomitant coronary artery bypass grafting or aortic surgery were excluded. To construct a cohort at risk for incident mental disorders, we excluded patients with a diagnosis of depression, anxiety disorder , or sleep disorder within one year prior to the index date. These conditions were identified using International Classification of Diseases, Tenth Revision codes recorded in claims data.

The exposure of interest was the type of prosthetic valve implanted at the index surgery. Patients were classified into mutually exclusive groups based on the prosthesis type recorded at the index procedure. The primary outcome was incident mental disorder after valve replacement, defined as a composite of depression, and anxiety disorder.

详细描述

Patients were enrolled if the patients aged 60 to 70 years who underwent surgical aortic or mitral valve replacement between January 1, 2013 and December 31, 2023 using procedure codes recorded in inpatient claims (N=5,428). The age range was restricted to 60 to 70 years to ensure comparability in surgical indications between prosthesis types. Patients who underwent concomitant coronary artery bypass grafting or aortic surgery were excluded (n=2,404). To construct a cohort at risk for incident mental disorders, we excluded patients with a diagnosis of depression (n=304), anxiety disorder (n=365), or sleep disorder (n=324) within one year prior to the index date. These conditions were identified using International Classification of Diseases, Tenth Revision codes recorded in claims data.

The exposure of interest was the type of prosthetic valve implanted at the index surgery. Mechanical prostheses were identified using procedure codes G200, G202, and G204, whereas biologic prostheses were identified using codes G201 and G203. Patients were classified into mutually exclusive groups based on the prosthesis type recorded at the index procedure. The primary outcome was incident mental disorder after valve replacement, defined as a composite of depression, and anxiety disorder. Depression was defined using ICD-10 codes F32 and F33. Anxiety disorder was defined using codes F40 and F41.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
60 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 60 to 70 years who underwent surgical aortic or mitral valve replacement between January 1, 2013 and December 31, 2023 using procedure codes recorded in inpatient claims

排除标准

  • Patients with a diagnosis of depression (n=307), anxiety disorder (n=263), or sleep disorder (n=197) within one year prior to the index date.

研究组 & 干预措施

Mechanical prostheses

Patients who received mechanical prostheses

Biologic prostheses

Patients who received biologic prostheses

结局指标

主要结局

Incident mental disorder after valve replacement

时间窗: 5 years after surgery

Defined as a composite of depression, anxiety disorder, and sleep disorder.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Danbee Kang

Associate Professor

Samsung Medical Center

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