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临床试验/NCT07089589
NCT07089589已完成不适用

Preoperative Statin Use and Major Adverse Cardiovascular Events in Liver Transplant Recipients: A Multicenter Retrospective Cohort Study

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 9,000 人开始时间: 2008年1月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
9,000
试验地点
1
主要终点
30-day Major Adverse Cardiovascular Events

研究概览

简要总结

The goal of this multicenter observational study is to determine whether preoperative statin use reduces major adverse cardiovascular events or other complications after liver transplantation. The main question it aims to answer is:

Does preoperative statin use reduce major adverse cardiovascular events or other complications after liver transplantation? The records of participants who already took statins before liver transplantation will be reviewed.

详细描述

Cardiovascular complications have emerged as a leading cause of early postoperative death following liver transplantation (LT), accounting for over 40% of early deaths. As a result, preventing postoperative cardiac complications has become a critical concern in the management of LT recipients.

Statin therapy has been suggested to improve perioperative and long-term outcomes in various surgical populations, primarily through LDL cholesterol reduction as well as pleiotropic effects, such as enhanced endothelial function and anti-inflammatory actions. However, evidence specifically examining the impact of preoperative statin therapy on cardiovascular outcomes after LT remains limited, highlighting the need for further research in this population.

This study aimed to address the current knowledge gap by investigating the association between preoperative statin use and the incidence of major adverse cardiovascular events within 30 days after liver transplantation in liver transplant recipients. Secondary outcomes included overall mortality, early allograft dysfunction, acute kidney injury, length of stay in the intensive care unit, duration of mechanical ventilation, and myocardial injury after non-cardiac surgery within 3 and 30 days after transplantation.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •- Adult patients aged ≥18 years who underwent liver transplantation

排除标准

  • •Patients who underwent liver re-transplantation
  • •Patients with preoperative acute-on-chronic liver failure (ACLF)
  • •Patients with preoperative fulminant hepatic failure

研究组 & 干预措施

Statin group

Patients who received preoperative statin therapy

干预措施: Preoperative Statin Use (Drug)

Control group

Patients who did not receive preoperative statin therapy

结局指标

主要结局

30-day Major Adverse Cardiovascular Events

时间窗: 30 days after liver transplantation

The composite of cardiovascular death, heart failure, myocardial infarction, atrial fibrillation, ventricular arrhythmia, ischemic electrocardiogram changes (ST-segment depression or elevation) with chest tightness, pulmonary embolism, and stroke

次要结局

  • Myocardial Injury after Non-Cardiac Surgery (MINS)(Within 3 days and 30 days after liver transplantation)
  • Acute Kidney Injury(Within 7 days after liver transplantation)
  • Overall Mortality(From the date of liver transplantation to May 19, 2025)
  • Early Allograft Dysfunction(Within 7 days after liver transplantation)
  • Intensive Care Unit Length of Stay(From the date of liver transplantation until intensive care unit discharge, up to 600 days)
  • Mechanical Ventilation Duration(From the date of transplantation until discontinuation of mechanical ventilation, up to 600 days)

研究者

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

Jun-Gol Song

Professor

Asan Medical Center

研究点 (1)

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