Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-03-10 @ 6:17 PM
Study NCT ID:
NCT01818505
Status:
UNKNOWN
Last Update Posted:
2014-04-14
First Post:
2013-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Antiphospholipid Antibodies on the Relationship Between Hyperurecemia, Gout and Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016736', 'term': 'Antiphospholipid Syndrome'}, {'id': 'D033461', 'term': 'Hyperuricemia'}, {'id': 'D006073', 'term': 'Gout'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D015210', 'term': 'Arthritis, Gouty'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'lastUpdateSubmitDate': '2014-04-11', 'studyFirstSubmitDate': '2013-03-21', 'studyFirstSubmitQcDate': '2013-03-25', 'lastUpdatePostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'development of metabolic syndrome or cardiovascular events', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'Acute myocardial infarct or stroke', 'timeFrame': '36 months or more'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['antiphospholipid syndrome', 'gouty arthritis', 'Hyperuricemia', 'metabolic syndrome', 'osteoarthritis', 'cardiovascular co-morbidities'], 'conditions': ['Antiphospholipid Syndrome', 'Endothelial Dysfunction', 'Hyperuricemia', 'Gout', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Patients with hyperuricemia were confirmed to have higher risks of cardiovascular disease, but the exact mechanism remained to be elucidated. Many connective tissue diseases such as rheumatoid arthritis are often associated with antiphospholipid antibodies-associated endothelial impairment. In the present study, the investigators will analyze the presence of antiphospholipid antibodies in the serum of the patients with gout/asymptomatic hyperuricemia, with a comparison to the patients of osteoarthritis but without hyperuricemia and gout. The investigators expect to find a correlation between these pathogenic antibody and those cardiovascular co-morbidities.', 'detailedDescription': "Patients with hyperuricemia were confirmed to have higher risks of cardiovascular disease, but the exact mechanism remained to be elucidated. Many connective tissue diseases such as rheumatoid arthritis are often associated with antiphospholipid antibodies-associated endothelial impairment. In the present study, we'll analyze the presence of antiphospholipid antibodies in the serum of the patients with gout/ asymptomatic hyperuricemia, with a comparison to the patients of osteoarthritis but without hyperuricemia and gout. We expect to find a correlation between these pathogenic antibody and those cardiovascular co-morbidities.\n\nPatient eligibility：\n\n1. Patients with gout\n2. Patients with asymptomatic hyperuricemia\n3. Patients of osteoarthritis but without hyperuricemia and gout Exclusion Criteria： Patients younger than 20 years old"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'General population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient with gouty arthritis\n2. Patient with asymptomatic hyperurecemia\n3. Patient of osteoarthritis but without hyperuricemia and gout\n\nExclusion Criteria:\n\n1.Patient younger than 20 y/o.'}, 'identificationModule': {'nctId': 'NCT01818505', 'acronym': 'URIC', 'briefTitle': 'The Influence of Antiphospholipid Antibodies on the Relationship Between Hyperurecemia, Gout and Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Influence of Antiphospholipid Antibodies on the Relationship Between Hyperurecemia, Gout and Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'URIC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gouty arthritis', 'description': 'Patient with gouty arthritis'}, {'label': 'Asymptomatic hyperuricemia', 'description': 'Patient with asymptomatic hyperuricemia'}, {'label': 'OA without hyperuricemia', 'description': 'Patient of osteoarthritis but without hyperuricemia and gout'}]}, 'contactsLocationsModule': {'locations': [{'zip': '640', 'city': 'Dou-Liou City', 'state': 'Yun-Lin County', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yu-Minn Kuo, MD', 'role': 'CONTACT', 'email': '543goole@gmail.com', 'phone': '8655323911', 'phoneExt': '5826'}], 'facility': 'National Taiwan University Hospital Yun-Lin Branch'}], 'centralContacts': [{'name': 'Yu-Min Kuo, M.D.', 'role': 'CONTACT', 'email': '543goole@gmail.com', 'phone': '886972655701'}], 'overallOfficials': [{'name': 'Yu-Min Kuo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}