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

• Conditions: Intracerebral Hemorrhage; Peripheral Arterial Disease; Myocardial Infarction; Cardiac Arrest; Subarachnoid Hemorrhage; Abdominal Aortic Aneurysm; Atrial Fibrillation; Stable Angina; Unheralded Coronary Heart Disease Death; Heart Failure

• Registration Number: NCT03425305
• Lead Sponsor: University College, London

Brief Summary

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

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 Timeline

• Study Start: 1998-01
• Status Verified: 2017-11
• Study First Submitted: 2018-01-24
• Primary Completion: 2018-02
• Study First Submitted QC: 2018-02-06
• Last Update Submitted: 2018-02-06
• Study First Posted: 2018-02-07
• Last Update Posted: 2018-02-07
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Initial presentation of cardiovascular diseases	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).

Secondary Outcome Measures

Name	Time	Method
All cause mortality	15 years