- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07757282
Peripheral Blood Lipidomic and Ceramide Profiles in Atrial Fibrillation (LIPID-AF)
Association of Peripheral Blood Lipidomic and Ceramide Profiles With Atrial Fibrillation: A Prospective Multi-Cohort Observational Study
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Weiyan Zhang
- Telefonnummer: 0086-13571200428
- E-post: zwhy19324@gmail.com
Studera Kontakt Backup
- Namn: Weiyan Zhang
- Telefonnummer: 0086-13571200428
- E-post: 3093887704@qq.com
Studieorter
-
-
Shaanxi
-
Xi'an, Shaanxi, Kina, 710061
- Rekrytering
- First Affiliated Hospital of Xian JiaotongUniversity
-
Kontakt:
- Weiyan Zhang
- Telefonnummer: 0086-13571200428
- E-post: zwhy19324@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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.
|
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.
|
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.
|
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.
|
Peripheral blood samples from cohort 2 will be analyzed using targeted ceramide assays.
No treatment or therapeutic intervention will be assigned by the investigators.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Peripheral Serum Concentration of Cer(d18:1/18:1), nmol/L
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- XJTU1AF-CRF-2018-025
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