Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-20 @ 11:25 AM
Study NCT ID:
NCT03616769
Status:
COMPLETED
Last Update Posted:
2021-03-24
First Post:
2018-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Cohort Study of China Serum Uric Acid Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3535}, 'targetDuration': '6 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2018-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-22', 'studyFirstSubmitDate': '2018-07-31', 'studyFirstSubmitQcDate': '2018-07-31', 'lastUpdatePostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause mortality and cardiovascular mortality', 'timeFrame': 'rom November 2011 to June 2018', 'description': 'Cardiovascular events definitions: Hospitalized myocardial infarction was classified as definite or probable based on chest pain symptoms, cardiac enzyme levels, and electrocardiographic findings, or angioplasty28. Coronary heart disease was determined to be present if there was (1) electrocardiographic (ECG) evidence of a prior myocardial infarction, (2) prior coronary artery bypass surgery or angioplasty, (3) Coronary angiography show coronary heart disease, (4) have symptoms of angina and ECG revealed myocardial ischemia performance or laboratory tests showed cardiac enzymes increased and exclude other types of disease, (5) a self-reported history of a physician-diagnosed heart attack 29. CHD death was classified "definite" based on chest pain symptoms, hospital records, and medical history.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uric Acid Serum; Prospective;'], 'conditions': ['Uric Acid Serum']}, 'referencesModule': {'references': [{'pmid': '34109223', 'type': 'DERIVED', 'citation': 'Cang Y, Xu S, Zhang J, Ju J, Chen Z, Wang K, Li J, Xu Y. Serum Uric Acid Revealed a U-Shaped Relationship With All-Cause Mortality and Cardiovascular Mortality in High Atherosclerosis Risk Patients: The ASSURE Study. Front Cardiovasc Med. 2021 May 24;8:641513. doi: 10.3389/fcvm.2021.641513. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Uric acid is the final breakdown product of purine degradation in humans. The association between high serum uric acid levels and arterial stiffness as well as endothelial dysfunction has been demonstrated in humans and uric acid has been suggested to be an important modulator of the inflammatory process. But debates still existed for hyperuricemia and hypouricemia as an independent role,especially after controlling other traditional atherosclerotic risk.The aim of this study was, firstly, to verify the association between hyperuricemia and cardiovascular diseases,secondly,to assess whether hypouricemia was an independent risk factor impact for cardiovascular disea.', 'detailedDescription': 'The study is a longitudinal cohort study. The first cross-sectional survey was conducted in 2011. The eligible participants were followed up from November 2011 to June 2018 (mean follow-up months 68.71±11.35). During the followed-up time, 67 patients had missing data and 56 had no compliance. Thus, the study sample actually comprised 3,047 valid participants (1536 men, 1511 women) whose age older than or equal to 35 years (mean age 60.2±10.4 years) were followed up. A total of hospitalized patients were consecutively enrolled from cardiology department of Beijing and Shanghai. All subjects are under treatment because of cardiovascular diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'There were 3,535 participants from multi-central departments with multiple classical Framingham risk factors atherosclerosis, 76 of whom had missing follow-up data. Thus,the study sample actually comprised 3,047 valid participants whose age older than or equal to 35 years.All participants were followed up from November 2011 to June 2018. A total of hospitalized patients were consecutively enrolled from the cardiology department and under treatment because of cardiovascular diseases .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nage older than or equal to 35 years with multiple classical Framingham risk factors patients.\n\nExclusion Criteria:\n\nSevere congestive heart failure and Severe renal failure patients.Severe congestive heart failure was defined that above or equal to cardiac functional classify 3 formulated by New York Heart Association (NYHA). Severe renal failure was defined as an estimated glomerular filtration rate \\<60 ml/ min/1.73m2.'}, 'identificationModule': {'nctId': 'NCT03616769', 'acronym': 'ASSURE', 'briefTitle': 'A Prospective Cohort Study of China Serum Uric Acid Levels', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Relationship of Serum Uric Acid Levels With All Cause Mortality and Cardiovascular Mortality in Multiple Classical Framingham Risk Factors Patients After a Six-year Follow-up: a China Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'ASSURE'}, 'secondaryIdInfos': [{'id': '15GWZK1002', 'type': 'OTHER', 'domain': 'Key Subject Construction Project of Shanghai Municipal Commission of Health and Family Planning'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'quantiles of serum uric acid level', 'description': "quantiles according to the patient's serum uric acid level", 'interventionNames': ['Drug: antiplatelet drugs ,statins ,antihypertensive drugs']}], 'interventions': [{'name': 'antiplatelet drugs ,statins ,antihypertensive drugs', 'type': 'DRUG', 'description': 'According to the international guidelines, we treated patients who suffered from different disease.', 'armGroupLabels': ['quantiles of serum uric acid level']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "cardiology department of shanghai 10th people's hospital", 'investigatorFullName': 'Ya-Wei Xu', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}