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Peripheral Blood Lipidomic and Ceramide Profiles in Atrial Fibrillation (LIPID-AF)

7. srpna 2026 aktualizováno: She JianQing, First Affiliated Hospital Xi'an Jiaotong University

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

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

200

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

  • Jméno: Weiyan Zhang
  • Telefonní číslo: 0086-13571200428
  • E-mail: 3093887704@qq.com

Studijní místa

  • Čína
    • Shaanxi
      • Xi'an, Shaanxi, Čína, 710061
        • Nábor
        • First Affiliated Hospital of Xian JiaotongUniversity
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

The study population includes adult patients prospectively enrolled from clinical cardiovascular cohorts. Participants will include patients with atrial fibrillation diagnosed by Holter monitoring and control patients with other cardiovascular diseases without documented atrial fibrillation. All participants will provide peripheral blood samples for untargeted lipidomic profiling or targeted ceramide analysis.

Popis

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Jiný: Peripheral blood untargeted lipidomic profiling
Peripheral blood samples from cohort 1 will be analyzed using untargeted lipidomic profiling. No treatment or therapeutic intervention will be assigned by the investigators.
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.
Jiný: Peripheral blood untargeted lipidomic profiling
Peripheral blood samples from cohort 1 will be analyzed using untargeted lipidomic profiling. No treatment or therapeutic intervention will be assigned by the investigators.
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.
Jiný: Peripheral blood targeted ceramide assay
Peripheral blood samples from cohort 2 will be analyzed using targeted ceramide assays. No treatment or therapeutic intervention will be assigned by the investigators.
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.
Jiný: Peripheral blood targeted ceramide assay
Peripheral blood samples from cohort 2 will be analyzed using targeted ceramide assays. No treatment or therapeutic intervention will be assigned by the investigators.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Peripheral Serum Concentration of Cer(d18:1/18:1), nmol/L
Časové okno: 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.
Baseline
Peripheral Serum Concentration of Cer(d18:1/16:0), nmol/L
Časové okno: 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.
baseline
Peripheral Serum Concentration of Cer(d18:1/18:0), nmol/L
Časové okno: 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.
Baseline
Peripheral Serum Concentration of Cer(d18:1/20:0), nmol/L
Časové okno: 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.
Baseline
Peripheral Serum Concentration of Cer(d18:1/22:0), nmol/L
Časové okno: 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.
Baseline
Peripheral Serum Concentration of Cer(d18:1/24:0), nmol/L
Časové okno: 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.
Baseline
Peripheral Serum Concentration of Cer(d18:1/24:1), nmol/L
Časové okno: 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.
Baseline
Normalized Relative Abundance of Serum Cer(d18:1/18:1), AU
Časové okno: 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.
Baseline
Normalized Relative Abundance of Serum Cer(d18:1/16:0), AU
Časové okno: 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.
Baseline
Normalized Relative Abundance of Serum Cer(d18:1/18:0), AU
Časové okno: 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.
Baseline
Normalized Relative Abundance of Serum Cer(d18:1/20:0), AU
Časové okno: 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.
Baseline
Normalized Relative Abundance of Serum Cer(d18:1/22:0), AU
Časové okno: 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.
Baseline
Normalized Relative Abundance of Serum Cer(d18:1/24:0), AU
Časové okno: 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.
Baseline
Normalized Relative Abundance of Serum Cer(d18:1/24:1), AU
Časové okno: 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.
Baseline

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

First Affiliated Hospital Xi'an Jiaotong University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. června 2017

Primární dokončení (Odhadovaný)

1. ledna 2027

Dokončení studie (Odhadovaný)

1. února 2027

Termíny zápisu do studia

První předloženo

4. července 2026

První předloženo, které splnilo kritéria kontroly kvality

7. srpna 2026

První zveřejněno (Aktuální)

11. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • XJTU1AF-CRF-2018-025

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data will not be shared because the study involves clinical information and biological sample-related data. Data sharing is not planned beyond the approved study protocol and ethical approval.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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