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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03425305
• Other study ID #: CALIBER 16-176R
• Secondary ID: RP-PG-0407-10314
• Status: Active, not recruiting
• Phase: N/A
• First received: January 24, 2018
• Last updated: February 6, 2018
• Start date: January 1998
• Est. completion date: February 2019

Study information

• Verified date: November 2017
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180000
• Est. completion date: February 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Atrial Fibrillation
• Cardiac Arrest
• Cardiovascular Diseases
• Cerebral Hemorrhage
• Coronary Artery Disease
• Coronary Disease
• Heart Arrest
• Heart Diseases
• Heart Failure
• Hemorrhage
• Infarction
• Intracerebral Hemorrhage
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Myocardial Infarction
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Stable Angina
• Subarachnoid Hemorrhage
• Transient Ischaemic Attack
• Unheralded Coronary Heart Disease Death
• Unstable Angina

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University College, London	Medical Research Council, National Institute for Health Research, United Kingdom, Wellcome Trust

References & Publications (3)

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. — View 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. — View 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. Review. Erratum in: BMJ. 2017 Aug 8;358:j3799. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial presentation of cardiovascular diseases	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	All cause mortality		15 years

External Links

•   CALIBER web site and data portal