NCT03425305

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1998

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
20.1 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 7, 2018

Status Verified

November 1, 2017

Enrollment Period

20.1 years

First QC Date

January 24, 2018

Last Update Submit

February 6, 2018

Conditions

Stable AnginaUnstable AnginaMyocardial InfarctionUnheralded Coronary Heart Disease DeathHeart FailureCardiac ArrestTransient Ischaemic AttackIschemic StrokeSubarachnoid HemorrhageIntracerebral HemorrhagePeripheral Arterial DiseaseAbdominal Aortic AneurysmAtrial Fibrillation

Keywords

Serum uric acidCardiovascular diseaseAtherosclerosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • All cause mortality

    15 years

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients without a measurement of blood urate level during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 23220717BACKGROUND

  • 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.

    PMID: 28592419BACKGROUND

  • 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.

    PMID: 19563390BACKGROUND

Related Links

MeSH Terms

Conditions

Angina, StableAngina, UnstableMyocardial InfarctionHeart FailureHeart ArrestIschemic Attack, TransientIschemic StrokeSubarachnoid HemorrhageCerebral HemorrhagePeripheral Arterial DiseaseAortic Aneurysm, AbdominalAtrial FibrillationCardiovascular DiseasesAtherosclerosis

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsInfarctionIschemiaPathologic ProcessesNecrosisBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeIntracranial HemorrhagesHemorrhageArteriosclerosisArterial Occlusive DiseasesPeripheral Vascular DiseasesAortic AneurysmAneurysmAortic DiseasesArrhythmias, Cardiac

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2018

First Posted

February 7, 2018

Study Start

January 1, 1998

Primary Completion

February 1, 2018

Study Completion

February 1, 2019

Last Updated

February 7, 2018

Record last verified: 2017-11