ClinicalTrials.gg
Status unknownNCT03425305Updated Feb 7, 2018

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

An observational study in Stable Angina, Unstable Angina and Myocardial Infarction, sponsored by University College, London. Status unknown. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-07.

Sponsored by University College, London · Observational

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180,000
Ages
30 Years and older
Sex
All
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Study 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.

Read the 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).

02

Conditions studied

  • 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
03

In context

Angina, Stable

343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.

This study's enrollment of 180,000 is above the median of 508 across 103 observational studies indexed under Angina, Stable.

Browse Angina, Stable studies →

Lead sponsor

University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
180,000 participants (actual)
Patient registry
No
06

What researchers measure

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).

    Time frame: 15 years

Secondary outcomes

  1. All cause mortality

    Time frame: 15 years

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Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 23220717 ↗
  • 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. Erratum In: BMJ. 2017 Aug 8;358:j3799. doi: 10.1136/bmj.j3799. PubMed 28592419 ↗
  • 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. PubMed 19563390 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 1998 (actual). Primary completion is estimated for Feb 2018, 241 months after the start.

Of 52 observational studies under Angina, Stable, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 79. This study's planned 241 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2018
First posted
Feb 7, 2018
StartActual
Jan 1998
Primary completionEst.
Feb 2018
CompletionEst.
Feb 2019
Last update
Feb 7, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03425305
Collaborators
Wellcome Trust, National Institute for Health Research, United Kingdom, Medical Research Council
Responsible party
Sponsor
First posted
Feb 7, 2018
Start date
Jan 1998
Primary completion
Feb 2018 (estimated)
Completion
Feb 2019 (estimated)
Last update
Feb 7, 2018

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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