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

February 6, 2018 updated by: University College, London

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

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

180000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial presentation of cardiovascular diseases
Time Frame: 15 years
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).
15 years

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: 15 years
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Medical Research Council
Wellcome Trust
National Institute for Health Research, United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1998

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

January 24, 2018

First Submitted That Met QC Criteria

February 6, 2018

First Posted (Actual)

February 7, 2018

Study Record Updates

Last Update Posted (Actual)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALIBER 16-176R
  • RP-PG-0407-10314 (Other Grant/Funding Number: Wellcome Trust)
  • 086091/Z/08/Z (Other Grant/Funding Number: Wellcome Trust)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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