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临床试验/NCT06707506
NCT06707506已完成不适用

CT-Derived Metabolic Parameters as Predictors of Post-Operative Atrial Fibrillation Following Minimally Invasive Mitral Valve Surgery: The MiniMitral AF Study

Nemocnice AGEL Trinec-Podlesi a.s.0 个研究点目标入组 114 人开始时间: 2014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
发起方
入组人数
114
主要终点
postoperative atrial fibrillation development

研究概览

简要总结

This retrospective cohort study investigates how CT-derived tissue quality parameters, serving as markers of metabolic status, predict post-operative atrial fibrillation risk in patients undergoing minimally invasive mitral valve surgery. The study leverages established associations between adipose tissue characteristics and metabolic dysfunction to explore their potential role in post-surgical arrhythmogenesis.

详细描述

Scientific Background and Rationale Post-operative atrial fibrillation (POAF) affects up to 30% of patients following cardiac surgery and significantly impacts outcomes. While traditional risk factors are well-documented, the role of underlying metabolic dysfunction in arrhythmogenesis remains poorly understood. Recent evidence suggests that tissue-specific metabolic alterations, particularly in adipose tissue distribution and quality, may provide crucial insights into arrhythmic risk. CT-derived tissue quality parameters (measured in Hounsfield Units) have been validated as markers of metabolic status, with studies demonstrating associations between adipose tissue density and inflammatory states. This study aims to investigate whether these metabolic markers can predict POAF risk in the specific context of mitral valve surgery, potentially informing risk stratification and preventive strategies.

Primary Objective To determine whether CT-derived tissue quality parameters (adipose tissue density, muscle density) independently predict post-operative atrial fibrillation risk following minimally invasive mitral valve surgery.

Study Design

Observational Model: Retrospective Cohort Setting: Single-center study at Complex Cardiovascular Center, Hospital AGEL Trinec-Podlesi Time Frame: January 2014 - November 2023 Follow-up: Through August 1, 2024

Primary Outcome Measure Post-operative Atrial Fibrillation [Time Frame: Up to 30 days post-surgery]

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
19 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Undergoing minimally invasive mitral valve surgery
  • Preoperative CT scan available
  • Surgery between January 2014 and November 2023

排除标准

  • Incomplete clinical data
  • Poor quality CT images
  • Previous cardiac surgery

结局指标

主要结局

postoperative atrial fibrillation development

时间窗: Through August 1, 2024

Defined as new-onset AF lasting more than 48 hours or requiring intervention Measured through continuous cardiac monitoring Analyzed separately for patients with and without preoperative AF history

次要结局

  • Overall Survival(Through August 1, 2024)
  • Perioperative Complications(Through August 1, 2024)

研究者

发起方
Nemocnice AGEL Trinec-Podlesi a.s.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matej Pekar, MD, PhD

Matej Pekar, MD, PhD

Nemocnice AGEL Trinec-Podlesi a.s.

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