Serum Uric Acid Levels and Onset of Cardiovascular Diseases: a CALIBER Study

NCT ID: NCT03425305

Last Updated: 2018-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180000 participants

Study Classification

OBSERVATIONAL

Study Start Date

1998-01-31

Study Completion Date

2019-02-28

Brief Summary

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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.

Detailed Description

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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.

The aim of this study is to estimate associations between serum uric acid level and initial presentation of a range of cardiovascular diseases.

The 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.

This 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).

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients registered with a participating general practice during the study period
* Age 30 years or older at study entry
* No record of previous diagnosis of cardiovascular disease
* Follow up for at least one year before the index date.

Exclusion Criteria

* Patients without a measurement of blood urate level during the study period.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wellcome Trust

OTHER

Sponsor Role collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Medical Research Council

OTHER_GOV

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type BACKGROUND
PMID: 23220717 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28592419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19563390 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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http://www.caliberresearch.org/

CALIBER web site and data portal

Other Identifiers

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RP-PG-0407-10314

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

086091/Z/08/Z

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CALIBER 16-176R

Identifier Type: -

Identifier Source: org_study_id

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