White Blood Cell Counts and Onset of Cardiovascular Diseases: a CALIBER Study

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Brief Title

White Blood Cell Counts and Onset of Cardiovascular Diseases: a CALIBER Study

Official Title

Leukocyte Counts and Initial Presentation of Cardiovascular Diseases: a CALIBER Study

Brief Summary

      The complete blood count is a commonly performed blood test, and previous small studies have
      suggested that the counts of some types of white blood cell in the complete blood count may
      be related to the onset of cardiovascular diseases such as stroke and heart attack. This is
      of interest because this information may help to predict strokes or heart attacks and may
      guide new therapies which act on white blood cells to reduce the risk of cardiovascular
      disease.

      The hypothesis is that counts of particular types of white blood cell are associated with a
      range of cardiovascular diseases.

Detailed Description

      There is evidence from epidemiological studies that counts of some types of white blood cell,
      such as neutrophils, are associated with increased incidence of coronary disease.
      Associations with other initial presentations of cardiovascular diseases have not been
      studied in large cohorts, 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 counts of lymphocytes, neutrophils,
      eosinophils, monocytes and basophils, 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 full blood count
      (complete blood count) 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 (Cardiovascular disease research using linked bespoke
      studies and electronic records) programme funded over 5 years from the National Institute for
      Health Research (NIHR) and Wellcome Trust. The central theme of the CALIBER research is
      linkage of the Myocardial Ischaemia National Audit Project (MINAP) 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

Primary Outcome

Initial presentation of cardiovascular disease

Secondary Outcome

 All cause mortality

Condition

Abdominal Aortic Aneurysm

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

800000

Start Date

January 1997

Completion Date

December 2014

Primary Completion Date

December 2013

Eligibility Criteria

        Inclusion Criteria:

          -  All patients aged 30 and over, registered with a participating general practice during
             the study period.

        Exclusion Criteria:

          -  Patients without a measurement of full blood count during the study period.

          -  Patients with prior atherosclerotic disease, as recorded in primary care or
             hospitalisation data.

Gender

All

Ages

30 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Anoop D Shah, MRCP, ,

Administrative Informations

NCT ID

NCT02014610

Organization ID

CALIBER 13-15

Secondary IDs

0938/30/Z/10/Z

Responsible Party

Sponsor

Study Sponsor

University College, London

Collaborators

 Wellcome Trust

Study Sponsor

Anoop D Shah, MRCP, Principal Investigator, University College, London

Verification Date

December 2013