Peripheral Blood Lipidomic and Ceramide Profiles in Atrial Fibrillation (LIPID-AF)
7 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
200
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Weiyan Zhang
- Número de teléfono: 0086-13571200428
- Correo electrónico: zwhy19324@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Weiyan Zhang
- Número de teléfono: 0086-13571200428
- Correo electrónico: 3093887704@qq.com
Ubicaciones de estudio
-
-
Shaanxi
-
Xi'an, Shaanxi, Porcelana, 710061
- Reclutamiento
- First Affiliated Hospital of Xian JiaotongUniversity
-
Contacto:
- Weiyan Zhang
- Número de teléfono: 0086-13571200428
- Correo electrónico: zwhy19324@gmail.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Peripheral Serum Concentration of Cer(d18:1/18:1), nmol/L
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de junio de 2017
Finalización primaria (Estimado)
1 de enero de 2027
Finalización del estudio (Estimado)
1 de febrero de 2027
Fechas de registro del estudio
Enviado por primera vez
4 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de agosto de 2026
Publicado por primera vez (Actual)
11 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- XJTU1AF-CRF-2018-025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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