- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Weiyan Zhang
- Phone Number: 0086-13571200428
- Email: zwhy19324@gmail.com
Study Contact Backup
- Name: Weiyan Zhang
- Phone Number: 0086-13571200428
- Email: 3093887704@qq.com
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710061
- Recruiting
- First Affiliated Hospital of Xian JiaotongUniversity
-
Contact:
- Weiyan Zhang
- Phone Number: 0086-13571200428
- Email: zwhy19324@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peripheral Serum Concentration of Cer(d18:1/18:1), nmol/L
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XJTU1AF-CRF-2018-025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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