Atrial FibrillationNCT05181787
Biomarkers of Atrial Fibrillation Complicated With Stroke Based on Proteomics and Metabolomics
An observational study of Atrial Fibrillation and Stroke, run by Yue LI at 1 site in China.
Trial summary
Thrombus shedding in patients with atrial fibrillation (AF) can lead to cerebral artery embolism. Stroke caused by AF is very dangerous, which not only threatens the life of patients, but also seriously affects the quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Proteomics and Metabolomics
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2021to 31 Dec 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 blood samples of patients with AF and patients with AF complicated with stroke were taken. The supernatant was centrifuged and put into - 80 ℃ refrigerator for storage.
Who may be able to join
- Age 18 years or above
- Admission with atrial fibrillation or clinic visit for atrial fibrillation
- Receive routine anticoagulant therapy;
- Signing the consent form
Who cannot join
- Pregnant women;
- Lactating women;
- Severe mitral stenosis;
- Severe impairment of liver function;
- Severe renal insufficiency;
- Thyroid dysfunction requiring treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yan
Harbin, Heilongjiang, 150001
Yan Shi, MD, +8645185555671, yidashijing@163.com
About this study
Thrombus shedding in patients with atrial fibrillation (AF) can lead to cerebral artery embolism. Stroke caused by AF is very dangerous, which not only threatens the life of patients, but also seriously affects the quality of life. This study aims to explore the biomarkers of stroke in patients with AF by integrating proteomics and metabolomics data, and establish the network relationship of stroke in patients with AF, so as to reveal the molecular mechanism of stroke in patients with AF.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Proteomics, Metabolomics
- Keywords
- Atrial Fibrillation, Stroke, metabolomics, proteomics, Biomarkers
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProteomicsDiagnostic test
Proteomic data were obtained by LC-MS/MS Analysis-DIA platform.
MetabolomicsDiagnostic test
Metabolomic data were obtained by UPLC-QTOF/MS platform.
| Study group | Role | What they receive |
|---|---|---|
| AF | Patients with AF Receives: Diagnostic Test: Proteomics; Diagnostic Test: Metabolomics | |
| AF and stroke | Patients with AF complicated with stroke Receives: Diagnostic Test: Proteomics; Diagnostic Test: Metabolomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers of atrial fibrillation complicated with stroke based on proteomics and metabolomics
By combining proteomics and metabolomics data, the investigators were able to identify the common pathways involved in AF with stroke.
Measured: 1 day
Secondary outcomes (3)
Quantitative changes of individual metabolites and proteins were calculated and graphed using the KEGG mapping tools.
Measured: 1 day
By combining proteomics and metabolomics data, the investigators were able to identify the common pathways involved in AF with stroke.
Measured: 1 day
All of the omics data were used to compare proteins/enzymes with metabolic pathways.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start20 Dec 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Yue LI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yue LI, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181787
- Sponsor's protocol ID
- AF and stroke 1
- Status last verified
- Jan 2022
- First submitted
- 20 Dec 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Atrial Fibrillation Complicated With Stroke Based on Proteomics and Metabolomics
- ClinicalTrials.gov ID
- NCT05181787
- Acronym / sponsor ID
- AF and stroke 1
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- Atrial Fibrillation, Stroke, metabolomics, proteomics, Biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yue LIUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Jan 2022 (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.
Thrombus shedding in patients with atrial fibrillation (AF) can lead to cerebral artery embolism. Stroke caused by AF is very dangerous, which not only threatens the life of patients, but also seriously affects the quality of life. This study aims to explore the biomarkers of stroke in patients with AF by integrating proteomics and metabolomics data, and establish the network relationship of stroke in patients with AF, so as to reveal the molecular mechanism of stroke in patients with AF.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF | – | Diagnostic Test: Proteomics, Diagnostic Test: MetabolomicsPatients with AF |
| AF and stroke | – | Diagnostic Test: Proteomics, Diagnostic Test: MetabolomicsPatients with AF complicated with stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The blood samples of patients with AF and patients with AF complicated with stroke were taken. The supernatant was centrifuged and put into - 80 ℃ refrigerator for storage.
Key inclusion criteria (4 listed)
- Age 18 years or above
- Admission with atrial fibrillation or clinic visit for atrial fibrillation
- Receive routine anticoagulant therapy;
- Signing the consent form
Key exclusion criteria (6 listed)
- Pregnant women;
- Lactating women;
- Severe mitral stenosis;
- Severe impairment of liver function;
- Severe renal insufficiency;
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 |
|---|---|---|
| ProteomicsProteomic data were obtained by LC-MS/MS Analysis-DIA platform. | Diagnostic test | AF, AF and stroke |
| MetabolomicsMetabolomic data were obtained by UPLC-QTOF/MS platform. | Diagnostic test | AF, AF and stroke |
Primary outcome
Biomarkers of atrial fibrillation complicated with stroke based on proteomics and metabolomics
Time frame: 1 day
By combining proteomics and metabolomics data, the investigators were able to identify the common pathways involved in AF with stroke.
3 secondary outcomes
Quantitative changes of individual metabolites and proteins were calculated and graphed using the KEGG mapping tools.
Time frame: 1 day
By combining proteomics and metabolomics data, the investigators were able to identify the common pathways involved in AF with stroke.
Time frame: 1 day
All of the omics data were used to compare proteins/enzymes with metabolic pathways.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 and Stroke, run by Yue LI 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 6 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: status not confirmed, as of the sponsor's last update on 25 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haiyu Zhang, MD (86-451-85555009, zhanghaiyu819@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers of atrial fibrillation complicated with stroke based on proteomics and metabolomics (time frame: 1 day). 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 25 Jan 2022.