Atrial Fibrillation (AF)LIPID-AFNCT07757282
Peripheral Blood Lipidomic and Ceramide Profiles in Atrial Fibrillation
An observational study of Atrial Fibrillation (AF), run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Peripheral blood untargeted lipidomic profiling and Peripheral blood targeted ceramide assay
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2017to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian JiaotongUniversity
Xi'an, Shaanxi, 710061
Weiyan Zhang, 0086-13571200428, zwhy19324@gmail.com
About this study
Official title: 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.
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.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Peripheral blood untargeted lipidomic profiling, Peripheral blood targeted ceramide assay
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood untargeted lipidomic profilingOther
Peripheral blood samples from cohort 1 will be analyzed using untargeted lipidomic profiling. No treatment or therapeutic intervention will be assigned by the investigators.
Peripheral blood targeted ceramide assayOther
Peripheral blood samples from cohort 2 will be analyzed using targeted ceramide assays. No treatment or therapeutic intervention will be assigned by the investigators.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Peripheral blood targeted ceramide assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start15 Jun 2017
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, She JianQing, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757282
- Sponsor's protocol ID
- XJTU1AF-CRF-2018-025
- Acronym
- LIPID-AF
- Status last verified
- Aug 2026
- First submitted
- 4 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Peripheral Blood Lipidomic and Ceramide Profiles With Atrial Fibrillation: A Prospective Multi-Cohort Observational Study
- ClinicalTrials.gov ID
- NCT07757282
- Acronym / sponsor ID
- LIPID-AF / XJTU1AF-CRF-2018-025
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Atrial Fibrillation Group | – | Other: Peripheral blood untargeted lipidomic profilingParticipants in cohort 1 diagnosed with atrial fibrillation based on Holter monitoring. Peripheral blood samples will be analyzed using untargeted lipidomic profiling. |
| Cohort 1 Control Group | – | Other: Peripheral blood untargeted lipidomic profilingControl participants in cohort 1 with other cardiovascular diseases and no documented atrial fibrillation. Peripheral blood samples will be analyzed using untargeted lipidomic profiling. |
| Cohort 2 Atrial Fibrillation Group | – | Other: Peripheral blood targeted ceramide assayParticipants in cohort 2 diagnosed with atrial fibrillation based on Holter monitoring. Peripheral blood samples will be analyzed using targeted ceramide assays. |
| Cohort 2 Control Group | – | Other: Peripheral blood targeted ceramide assayControl participants in cohort 2 with other cardiovascular diseases and no documented atrial fibrillation. Peripheral blood samples will be analyzed using targeted ceramide assays. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral blood untargeted lipidomic profilingPeripheral blood samples from cohort 1 will be analyzed using untargeted lipidomic profiling. No treatment or therapeutic intervention will be assigned by the investigators. | Other | Cohort 1 Atrial Fibrillation Group, Cohort 1 Control Group |
| Peripheral blood targeted ceramide assayPeripheral blood samples from cohort 2 will be analyzed using targeted ceramide assays. No treatment or therapeutic intervention will be assigned by the investigators. | Other | Cohort 2 Atrial Fibrillation Group, Cohort 2 Control Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weiyan Zhang (0086-13571200428, zwhy19324@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral Serum Concentration of Cer(d18:1/18:1), nmol/L (time frame: Baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.