Atrial FibrillationNCT06119802
Prediction of UA/SOD Ratio as a Biomarker of Oxidative Stress in Atrial Fibrillation
An observational study of Atrial Fibrillation and Hyperuricemia, run by Yinglong Hou at 1 site in China.
Trial summary
To clarify the predictive effects of uric acid and superoxide dismutase as biomarkers of oxidative stress on atrial fibrillation, and to provide greater value for the diagnosis and prediction of atrial fibrillation. It provides a new idea for the prevention and treatment of atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Hyperuricemia
- What is being tested?
- atrial fibrillation
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Apr 2024
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This retrospective study enrolled all hospitalized patients from January 2018 to December 2020 at the Department of Cardiology in The First Affiliated Hospital of Shandong First Medical University.
Who may be able to join
None listed.
Who cannot join
- acute heart failure and acute myocardial infarction;
- severe liver or kidney dysfunction (with aspartate aminotransferase or alanine aminotransferase levels three times higher than normal and estimated glomerular filtration rate <30 ml/ (min*1.73 m2));
- malignant tumors;
- missing data of laboratory indicators at baseline.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong provincal Qianfoshan hospital
Jinan, Shandong, 250014
Hui Tian, PhD, 053189269217, 13791121081@163.com
About this study
To clarify the predictive effects of uric acid and superoxide dismutase as biomarkers of oxidative stress on atrial fibrillation, and to provide greater value for the diagnosis and prediction of atrial fibrillation. It provides a new idea for the prevention and treatment of atrial fibrillation.
Read the detailed description
In recent years, a growing number of reports have shown the importance of oxidative stress in the pathophysiological mechanism of AF. During oxidative stress, there is an imbalance between the production of pro-oxidant reactive species and the antioxidant defenses of the cell, and excessive oxidation leads to oxidative damage and cell death. Redox processes can lead to atrial fibrosis and cardiac remodeling , suggesting that strategies to address myocardial oxidative stress may constitute a reasonable approach for the treatment of AF. However, few studies have reported the relationship between comprehensive oxidative stress-related biomarkers and AF. The purpose of this study was to illuminate the relationship of several blood markers of oxidative stress with AF and to provide new clues for the prevention and treatment of AF.
- Conditions
- Atrial Fibrillation, Hyperuricemia
- Being tested
- atrial fibrillation
- Keywords
- hyperuricemia, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atrial fibrillationDiagnostic test
ECG of atrial fibrillation last more than 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation cohort | The diagnosis of AF was based on 12-lead electrocardiography (ECG) or 24-hour Holter monitoring, and classification was based on the published 2020 ESC guidelines for the diagnosis and management of AF. The exclusion criteria were as follows: (1) acute heart failure and acute myocardial infarction; (2) severe liver or kidney dysfunction (with aspartate aminotransferase or alanine aminotransferase levels three times higher than normal and estimated glomerular filtration rate <30 ml/ (min*1.73 m2)); (3) malignant tumors; and (4) missing data of laboratory indicators at baseline. Receives: Diagnostic Test: atrial fibrillation | |
| Non-atrial Fibrillation cohort | Patients attending the Department of Cardiology to rule out atrial fibrillation.The exclusion criteria were as follows: (1) acute heart failure and acute myocardial infarction; (2) severe liver or kidney dysfunction (with aspartate aminotransferase or alanine aminotransferase levels three times higher than normal and estimated glomerular filtration rate <30 ml/ (min*1.73 m2)); (3) malignant tumors; and (4) missing data of laboratory indicators at baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uric acid/SOD ratio is associated with atrial fibrillation
Uric acid/SOD ratio is associated with atrial fibrillation
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jan 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion30 Apr 2024 (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
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yinglong Hou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yinglong Hou, Qianfoshan Hospital
- Investigators
- Hui Tian, PhD, Study chair, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119802
- Sponsor's protocol ID
- YXLL-KY-2023(044)
- Status last verified
- Nov 2023
- First submitted
- 6 Sep 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of UA/SOD Ratio as a Biomarker of Oxidative Stress in Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06119802
- Acronym / sponsor ID
- YXLL-KY-2023(044)
- Conditions
- Atrial Fibrillation, Hyperuricemia
- Keywords
- hyperuricemia, atrial fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Yinglong HouUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 7 Nov 2023 (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.
To clarify the predictive effects of uric acid and superoxide dismutase as biomarkers of oxidative stress on atrial fibrillation, and to provide greater value for the diagnosis and prediction of atrial fibrillation. It provides a new idea for the prevention and treatment of atrial fibrillation.
Detailed description
In recent years, a growing number of reports have shown the importance of oxidative stress in the pathophysiological mechanism of AF. During oxidative stress, there is an imbalance between the production of pro-oxidant reactive species and the antioxidant defenses of the cell, and excessive oxidation leads to oxidative damage and cell death. Redox processes can lead to atrial fibrosis and cardiac remodeling , suggesting that strategies to address myocardial oxidative stress may constitute a reasonable approach for the treatment of AF. However, few studies have reported the relationship between comprehensive oxidative stress-related biomarkers and AF. The purpose of this study was to illuminate the relationship of several blood markers of oxidative stress with AF and to provide new clues for the prevention and treatment of AF.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation cohort | – | Diagnostic Test: atrial fibrillationThe diagnosis of AF was based on 12-lead electrocardiography (ECG) or 24-hour Holter monitoring, and classification was based on the published 2020 ESC guidelines for the diagnosis and management of AF. The exclusion criteria were as follows: (1) acute heart failure and acute myocardial infarction; (2) severe liver or kidney dysfunction (with aspartate aminotransferase or alanine aminotransferase levels three times higher than normal and estimated glomerular filtration rate <30 ml/ (min*1.73 m2)); (3) malignant tumors; and (4) missing data of laboratory indicators at baseline. |
| Non-atrial Fibrillation cohort | – | –Patients attending the Department of Cardiology to rule out atrial fibrillation.The exclusion criteria were as follows: (1) acute heart failure and acute myocardial infarction; (2) severe liver or kidney dysfunction (with aspartate aminotransferase or alanine aminotransferase levels three times higher than normal and estimated glomerular filtration rate <30 ml/ (min*1.73 m2)); (3) malignant tumors; and (4) missing data of laboratory indicators at baseline. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study enrolled all hospitalized patients from January 2018 to December 2020 at the Department of Cardiology in The First Affiliated Hospital of Shandong First Medical University.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- acute heart failure and acute myocardial infarction;
- severe liver or kidney dysfunction (with aspartate aminotransferase or alanine aminotransferase levels three times higher than normal and estimated glomerular filtration rate <30 ml/ (min*1.73 m2));
- malignant tumors;
- missing data of laboratory indicators at baseline.
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 |
|---|---|---|
| atrial fibrillationECG of atrial fibrillation last more than 30 seconds. | Diagnostic test | Atrial Fibrillation cohort |
Primary outcome
Uric acid/SOD ratio is associated with atrial fibrillation
Time frame: 3 years
Uric acid/SOD ratio is associated with atrial fibrillation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
Hui Tian, PhD study chair
Qianfoshan Hospital
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 Hyperuricemia, run by Yinglong Hou 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 0 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. 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 Yinglong Hou, PhD (13791120810, yujiao61@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uric acid/SOD ratio is associated with atrial fibrillation (time frame: 3 years). 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 7 Nov 2023.