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

7. august 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710061
        • Rekruttering
        • First Affiliated Hospital of Xian JiaotongUniversity
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Annen: 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.
Annen: 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.
Annen: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. juni 2017

Primær fullføring (Antatt)

1. januar 2027

Studiet fullført (Antatt)

1. februar 2027

Datoer for studieregistrering

Først innsendt

4. juli 2026

Først innsendt som oppfylte QC-kriteriene

7. august 2026

Først lagt ut (Faktiske)

11. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • XJTU1AF-CRF-2018-025

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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