Peripheral Blood Lipidomic and Ceramide Profiles in Atrial Fibrillation (LIPID-AF)
7 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
200
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Weiyan Zhang
- Numéro de téléphone: 0086-13571200428
- E-mail: zwhy19324@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Weiyan Zhang
- Numéro de téléphone: 0086-13571200428
- E-mail: 3093887704@qq.com
Lieux d'étude
-
-
Shaanxi
-
Xi'an, Shaanxi, Chine, 710061
- Recrutement
- First Affiliated Hospital of Xian JiaotongUniversity
-
Contact:
- Weiyan Zhang
- Numéro de téléphone: 0086-13571200428
- E-mail: zwhy19324@gmail.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Peripheral Serum Concentration of Cer(d18:1/18:1), nmol/L
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 juin 2017
Achèvement primaire (Estimé)
1 janvier 2027
Achèvement de l'étude (Estimé)
1 février 2027
Dates d'inscription aux études
Première soumission
4 juillet 2026
Première soumission répondant aux critères de contrôle qualité
7 août 2026
Première publication (Réel)
11 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- XJTU1AF-CRF-2018-025
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .