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

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ClinicalTrials.gov Identifier: NCT03425305
Recruitment Status : Active, not recruiting
First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborators:
Wellcome Trust
National Institute for Health Research, United Kingdom
Medical Research Council
Information provided by (Responsible Party):
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.

Condition or disease
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

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).


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Study Type : Observational
Actual Enrollment : 180000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serum Uric Acid Levels and Initial Presentation of Cardiovascular Diseases: a CALIBER Study
Actual Study Start Date : January 1998
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Uric Acid




Primary Outcome Measures :
  1. Initial presentation of cardiovascular diseases [ Time Frame: 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 :
  1. All cause mortality [ Time Frame: 15 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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.
  Study Documents (Full-Text)

Documents provided by University College, London:
Study Protocol  [PDF] January 23, 2018


Additional Information:
Publications:
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03425305     History of Changes
Other Study ID Numbers: CALIBER 16-176R
RP-PG-0407-10314 ( Other Grant/Funding Number: UK National Institute for Health Research )
086091/Z/08/Z ( Other Grant/Funding Number: Wellcome Trust )
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: November 2017
Keywords provided by University College, London:
Serum uric acid
Cardiovascular disease
Atherosclerosis
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Cerebral Hemorrhage
Ischemic Attack, Transient
Atrial Fibrillation
Heart Diseases
Myocardial Infarction
Angina Pectoris
Coronary Disease
Aortic Aneurysm
Peripheral Arterial Disease
Peripheral Vascular Diseases
Aortic Aneurysm, Abdominal
Angina, Stable
Angina, Unstable
Ischemia
Hemorrhage
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Aneurysm
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Aortic Diseases
Atherosclerosis