Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT06119802
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2023-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prediction of UA/SOD Ratio as a Biomarker of Oxidative Stress in Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-01', 'studyFirstSubmitDate': '2023-09-06', 'studyFirstSubmitQcDate': '2023-11-01', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uric acid/SOD ratio is associated with atrial fibrillation', 'timeFrame': '3 years', 'description': 'Uric acid/SOD ratio is associated with atrial fibrillation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hyperuricemia', 'atrial fibrillation'], 'conditions': ['Atrial Fibrillation', 'Hyperuricemia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: 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. 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.\n\nExclusion Criteria:\n\n1. acute heart failure and acute myocardial infarction;\n2. 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));\n3. malignant tumors;\n4. missing data of laboratory indicators at baseline.'}, 'identificationModule': {'nctId': 'NCT06119802', 'briefTitle': 'Prediction of UA/SOD Ratio as a Biomarker of Oxidative Stress in Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Prediction of UA/SOD Ratio as a Biomarker of Oxidative Stress in Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'YXLL-KY-2023(044)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atrial Fibrillation cohort', 'description': '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.', 'interventionNames': ['Diagnostic Test: atrial fibrillation']}, {'label': 'Non-atrial Fibrillation cohort', 'description': '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.'}], 'interventions': [{'name': 'atrial fibrillation', 'type': 'DIAGNOSTIC_TEST', 'description': 'ECG of atrial fibrillation last more than 30 seconds.', 'armGroupLabels': ['Atrial Fibrillation cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250014', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Tian, PhD', 'role': 'CONTACT', 'email': '13791121081@163.com', 'phone': '053189269217'}], 'facility': 'Shandong provincal Qianfoshan hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yinglong Hou, PhD', 'role': 'CONTACT', 'email': 'yujiao61@163.com', 'phone': '13791120810'}], 'overallOfficials': [{'name': 'Hui Tian, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Qianfoshan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yinglong Hou', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Yinglong Hou', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}