Clinical trial NCT03425305: Serum Uric Acid Levels and Onset of Cardiovascular Diseases: a CALIBER Study
Official title: Serum Uric Acid Levels and Initial Presentation of Cardiovascular Diseases: a CALIBER Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Keywords: Serum uric acid
Cardiovascular disease
Atherosclerosis
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: National Institute for Health Research, United Kingdom
name: Medical Research Council
First posted: 2018-02-07
Enrollment: 180000
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Initial presentation of cardiovascular diseases
timeFrame: 15 years
Secondary outcomes:
measure: All cause mortality
timeFrame: 15 years
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.