Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    28592419 [PUBMED-IDS]
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03425305
Recruitment Status : Unknown
Verified November 2017 by University College, London.
Recruitment status was:  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

Tracking Information
First Submitted Date January 24, 2018
First Posted Date February 7, 2018
Last Update Posted Date February 7, 2018
Actual Study Start Date January 1998
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 6, 2018)
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).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 6, 2018)
All cause mortality [ Time Frame: 15 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • 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
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: February 6, 2018)
180000
Original Actual Enrollment Same as current
Estimated Study Completion Date February 2019
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03425305
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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University College, London
Study Sponsor University College, London
Collaborators
  • Wellcome Trust
  • National Institute for Health Research, United Kingdom
  • Medical Research Council
Investigators Not Provided
PRS Account University College, London
Verification Date November 2017