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RecruitingNCT07757282LIPID-AFUpdated Aug 11, 2026

Peripheral Blood Lipidomic and Ceramide Profiles in Atrial Fibrillation

An observational study in Atrial Fibrillation (AF), sponsored by First Affiliated Hospital Xi'an Jiaotong University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational

From the registry’s dates

  • Started Jun 2017; still recruiting 9 years 4 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Atrial Fibrillation (AF)

Browse trials for

03

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's planned enrollment of 200 is below the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 314 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18 years or older.
  • Participants who are able to provide .
  • 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

Exclusion Criteria:

  • Inability or unwillingness to provide .
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

    Other: Peripheral blood untargeted lipidomic profiling

  • 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.

    Other: Peripheral blood untargeted lipidomic profiling

  • 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.

    Other: Peripheral blood targeted ceramide assay

  • 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.

    Other: Peripheral blood targeted ceramide assay

Interventions

  • OtherPeripheral 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.

  • OtherPeripheral 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.

06

What researchers measure

Primary outcomes

  1. Peripheral Serum Concentration of Cer(d18:1/18:1), nmol/L

    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.

    Time frame: Baseline

  2. Peripheral Serum Concentration of Cer(d18:1/16:0), nmol/L

    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.

    Time frame: baseline

  3. Peripheral Serum Concentration of Cer(d18:1/18:0), nmol/L

    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.

    Time frame: Baseline

  4. Peripheral Serum Concentration of Cer(d18:1/20:0), nmol/L

    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.

    Time frame: Baseline

  5. Peripheral Serum Concentration of Cer(d18:1/22:0), nmol/L

    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.

    Time frame: Baseline

  6. Peripheral Serum Concentration of Cer(d18:1/24:0), nmol/L

    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.

    Time frame: Baseline

  7. Peripheral Serum Concentration of Cer(d18:1/24:1), nmol/L

    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.

    Time frame: Baseline

  8. Normalized Relative Abundance of Serum Cer(d18:1/18:1), AU

    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.

    Time frame: Baseline

  9. Normalized Relative Abundance of Serum Cer(d18:1/16:0), AU

    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.

    Time frame: Baseline

  10. Normalized Relative Abundance of Serum Cer(d18:1/18:0), AU

    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.

    Time frame: Baseline

  11. Normalized Relative Abundance of Serum Cer(d18:1/20:0), AU

    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.

    Time frame: Baseline

  12. Normalized Relative Abundance of Serum Cer(d18:1/22:0), AU

    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.

    Time frame: Baseline

  13. Normalized Relative Abundance of Serum Cer(d18:1/24:0), AU

    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.

    Time frame: Baseline

  14. Normalized Relative Abundance of Serum Cer(d18:1/24:1), AU

    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.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2017 (actual). Primary completion is estimated for Jan 2027, 115 months after the start.

Of 550 non-industry observational studies under Atrial Fibrillation, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 91. This study's planned 115 months is above that.

Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 4, 2026
First posted
Aug 11, 2026
StartActual
Jun 15, 2017
Primary completionEst.
Jan 2027
CompletionEst.
Feb 2027
Last update
Aug 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07757282
Responsible party
She JianQing (First Affiliated Hospital Xian Jiaotong University, First Affiliated Hospital Xi'an Jiaotong University) — Principal investigator
First posted
Aug 11, 2026
Start date
Jun 15, 2017
Primary completion
Jan 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Aug 11, 2026

Study contacts

Weiyan Zhang
Contact
zwhy19324@gmail.com
0086-13571200428
Weiyan Zhang
Contact
3093887704@qq.com
0086-13571200428

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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