跳至主要内容
临床试验/NCT07757282
NCT07757282招募中不适用

Association of Peripheral Blood Lipidomic and Ceramide Profiles With Atrial Fibrillation: A Prospective Multi-Cohort Observational Study

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Peripheral Serum Concentration of Cer(d18:1/18:1), nmol/L

研究概览

简要总结

This prospective multi-cohort observational study evaluates the association between peripheral blood lipidomic and ceramide profiles and atrial fibrillation. The study hypothesis is that peripheral blood lipidomic features and ceramide-related profiles are associated with the presence of atrial fibrillation. Participants with atrial fibrillation and control participants with other cardiovascular diseases will be prospectively enrolled. Peripheral blood samples will be analyzed using untargeted lipidomic profiling in one cohort and targeted ceramide assays in another cohort.

详细描述

Atrial fibrillation is a common cardiac arrhythmia associated with metabolic disturbance and cardiac remodeling. Lipid metabolism, including sphingolipid and ceramide metabolism, may be involved in the pathophysiology of atrial fibrillation. Further clinical evidence is needed to clarify whether peripheral blood lipidomic and ceramide profiles are associated with atrial fibrillation.

This study is designed as a prospective multi-cohort observational study. Participants will be classified into an atrial fibrillation group or a control group according to Holter monitoring and clinical information. Control participants will be patients with other cardiovascular diseases without documented atrial fibrillation. Peripheral blood samples will be collected for lipidomic or targeted ceramide analysis.

Untargeted lipidomic profiling will be used to evaluate peripheral blood lipidomic features in one cohort, and targeted ceramide assays will be used to evaluate peripheral blood ceramide profiles in another cohort. The overall purpose of this study is to explore the relationship between peripheral blood lipidomic and ceramide profiles and atrial fibrillation.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Adults aged 18 years or older.
  • Participants who are able to provide informed consent.
  • Participants diagnosed with atrial fibrillation based on Holter monitoring, or control participants with other cardiovascular diseases and no documented atrial fibrillation.
  • Participants with available peripheral blood samples for untargeted lipidomic profiling or targeted ceramide analysis.

排除标准

  • Inability or unwillingness to provide informed consent.
  • Missing key clinical information.
  • Missing or poor-quality peripheral blood samples unsuitable for lipidomic or targeted ceramide analysis.
  • Participants considered unsuitable for this study by the investigators.

研究组 & 干预措施

Cohort 1 Atrial Fibrillation Group

Participants in cohort 1 diagnosed with atrial fibrillation based on Holter monitoring. Peripheral blood samples will be analyzed using untargeted lipidomic profiling.

干预措施: Peripheral blood untargeted lipidomic profiling (Other)

Cohort 1 Control Group

Control participants in cohort 1 with other cardiovascular diseases and no documented atrial fibrillation. Peripheral blood samples will be analyzed using untargeted lipidomic profiling.

干预措施: Peripheral blood untargeted lipidomic profiling (Other)

Cohort 2 Atrial Fibrillation Group

Participants in cohort 2 diagnosed with atrial fibrillation based on Holter monitoring. Peripheral blood samples will be analyzed using targeted ceramide assays.

干预措施: Peripheral blood targeted ceramide assay (Other)

Cohort 2 Control Group

Control participants in cohort 2 with other cardiovascular diseases and no documented atrial fibrillation. Peripheral blood samples will be analyzed using targeted ceramide assays.

干预措施: Peripheral blood targeted ceramide assay (Other)

结局指标

主要结局

Peripheral Serum Concentration of Cer(d18:1/18:1), nmol/L

时间窗: Baseline

The concentration of Cer(d18:1/18:1) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.

Peripheral Serum Concentration of Cer(d18:1/16:0), nmol/L

时间窗: baseline

The concentration of Cer(d18:1/16:0) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.

Peripheral Serum Concentration of Cer(d18:1/18:0), nmol/L

时间窗: Baseline

The concentration of Cer(d18:1/18:0) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.

Peripheral Serum Concentration of Cer(d18:1/20:0), nmol/L

时间窗: Baseline

The concentration of Cer(d18:1/20:0) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.

Peripheral Serum Concentration of Cer(d18:1/22:0), nmol/L

时间窗: Baseline

The concentration of Cer(d18:1/22:0) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.

Peripheral Serum Concentration of Cer(d18:1/24:0), nmol/L

时间窗: Baseline

The concentration of Cer(d18:1/24:0) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.

Peripheral Serum Concentration of Cer(d18:1/24:1), nmol/L

时间窗: Baseline

The concentration of Cer(d18:1/24:1) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.

Normalized Relative Abundance of Serum Cer(d18:1/18:1), AU

时间窗: Baseline

The normalized relative abundance of Cer(d18:1/18:1) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.

Normalized Relative Abundance of Serum Cer(d18:1/16:0), AU

时间窗: Baseline

The normalized relative abundance of Cer(d18:1/16:0) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.

Normalized Relative Abundance of Serum Cer(d18:1/18:0), AU

时间窗: Baseline

The normalized relative abundance of Cer(d18:1/18:0) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.

Normalized Relative Abundance of Serum Cer(d18:1/20:0), AU

时间窗: Baseline

The normalized relative abundance of Cer(d18:1/20:0) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.

Normalized Relative Abundance of Serum Cer(d18:1/22:0), AU

时间窗: Baseline

The normalized relative abundance of Cer(d18:1/22:0) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.

Normalized Relative Abundance of Serum Cer(d18:1/24:0), AU

时间窗: Baseline

The normalized relative abundance of Cer(d18:1/24:0) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.

Normalized Relative Abundance of Serum Cer(d18:1/24:1), AU

时间窗: Baseline

The normalized relative abundance of Cer(d18:1/24:1) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.

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

She JianQing

First Affiliated Hospital Xian Jiaotong University

First Affiliated Hospital Xi'an Jiaotong University

研究点 (1)

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