Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT03425305
Status:
UNKNOWN
Last Update Posted:
2018-02-07
First Post:
2018-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serum Uric Acid Levels and Onset of Cardiovascular Diseases: a CALIBER Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-23', 'size': 136861, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-02-06T05:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1998-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2018-01-24', 'studyFirstSubmitQcDate': '2018-02-06', 'lastUpdatePostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initial presentation of cardiovascular diseases', 'timeFrame': '15 years', 'description': 'First recorded diagnosis of cardiovascular disease during follow-up: Stable angina, unstable angina, myocardial infarction, unheralded coronary heart disease death, heart failure, cardiac arrest/sudden cardiac death, transient ischaemic attack, ischaemic stroke, subarachnoid haemorrhage, intracerebral haemorrhage, peripheral arterial disease, abdominal aortic aneurysm, atrial fibrillation. We will identify the diagnoses using ICD-10 or Read codes in the linked data sources. Definitions for each endpoint are provided on the CALIBER data portal (https://www.caliberresearch.org/portal).'}], 'secondaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': '15 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Serum uric acid', 'Cardiovascular disease', 'Atherosclerosis'], 'conditions': ['Stable Angina', 'Unstable Angina', 'Myocardial Infarction', 'Unheralded Coronary Heart Disease Death', 'Heart Failure', 'Cardiac Arrest', 'Transient Ischaemic Attack', 'Ischemic Stroke', 'Subarachnoid Hemorrhage', 'Intracerebral Hemorrhage', 'Peripheral Arterial Disease', 'Abdominal Aortic Aneurysm', 'Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '23220717', 'type': 'BACKGROUND', 'citation': 'Denaxas SC, George J, Herrett E, Shah AD, Kalra D, Hingorani AD, Kivimaki M, Timmis AD, Smeeth L, Hemingway H. Data resource profile: cardiovascular disease research using linked bespoke studies and electronic health records (CALIBER). Int J Epidemiol. 2012 Dec;41(6):1625-38. doi: 10.1093/ije/dys188. Epub 2012 Dec 5.'}, {'pmid': '28592419', 'type': 'BACKGROUND', 'citation': 'Li X, Meng X, Timofeeva M, Tzoulaki I, Tsilidis KK, Ioannidis JP, Campbell H, Theodoratou E. Serum uric acid levels and multiple health outcomes: umbrella review of evidence from observational studies, randomised controlled trials, and Mendelian randomisation studies. BMJ. 2017 Jun 7;357:j2376. doi: 10.1136/bmj.j2376.'}, {'pmid': '19563390', 'type': 'BACKGROUND', 'citation': 'Holme I, Aastveit AH, Hammar N, Jungner I, Walldius G. Uric acid and risk of myocardial infarction, stroke and congestive heart failure in 417,734 men and women in the Apolipoprotein MOrtality RISk study (AMORIS). J Intern Med. 2009 Dec;266(6):558-70. doi: 10.1111/j.1365-2796.2009.02133.x. Epub 2009 May 26.'}], 'seeAlsoLinks': [{'url': 'http://www.caliberresearch.org/', 'label': 'CALIBER web site and data portal'}]}, 'descriptionModule': {'briefSummary': 'Serum uric acid level is a commonly measured biomarker. The association between serum uric acid level and the risk of developing cardiovascular diseases has been observed in some studies, while others showed controversial results. Estimation of this association may help to predict cardiovascular outcomes and may guide new treatment strategies. The hypothesis is that increased serum uric acid level is associated with a range of cardiovascular diseases.', 'detailedDescription': 'Smaller observational studies suggested that increased serum uric acid level is associated with increased incidence of several cardiovascular diseases. Associations with specific initial presentations of cardiovascular diseases have not been studied in large cohort from the general population, but may be of interest for use in risk prediction or to guide therapeutic strategies.\n\nThe aim of this study is to estimate associations between serum uric acid level and initial presentation of a range of cardiovascular diseases.\n\nThe study will use data from the CALIBER dataset of clinically collected electronic health record data from England. Patients enter the study when they have a blood urate measurement recorded in the dataset, and they are followed up until they experience one of the cardiovascular endpoints, death or transfer out of the participating primary care practice.\n\nThis study is part of the CALIBER (Clinical disease research using linked bespoke studies and electronic records) programme funded from the National Institute for Health Research (NIHR) and Wellcome Trust. The central theme of the CALIBER research is linkage of the Inpatient Hospital Episode Statistics (HES) with primary care (Clinical Practice Research Datalink) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cohort study of patients in the CALIBER database who have a record of a blood urate measurement during the study period while registered at one of 225 general practices contributing data to CPRD (the Clinical Practice Research Datalink) and consenting to data linkage.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients registered with a participating general practice during the study period\n* Age 30 years or older at study entry\n* No record of previous diagnosis of cardiovascular disease\n* Follow up for at least one year before the index date.\n\nExclusion Criteria:\n\n* Patients without a measurement of blood urate level during the study period.'}, 'identificationModule': {'nctId': 'NCT03425305', 'briefTitle': 'Serum Uric Acid Levels and Onset of Cardiovascular Diseases: a CALIBER Study', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'Serum Uric Acid Levels and Initial Presentation of Cardiovascular Diseases: a CALIBER Study', 'orgStudyIdInfo': {'id': 'CALIBER 16-176R'}, 'secondaryIdInfos': [{'id': 'RP-PG-0407-10314', 'type': 'OTHER_GRANT', 'domain': 'UK National Institute for Health Research'}, {'id': '086091/Z/08/Z', 'type': 'OTHER_GRANT', 'domain': 'Wellcome Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wellcome Trust', 'class': 'OTHER'}, {'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}, {'name': 'Medical Research Council', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}