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

NCT ID: NCT02014610

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800000 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-01-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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).

Conditions

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Abdominal Aortic Aneurysm Coronary Artery Disease Stroke Heart Failure Peripheral Arterial Disease

Keywords

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Neutrophil Lymphocyte Eosinophil Leukocyte count Cardiovascular disease Atherosclerosis Monocyte Basophil

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wellcome Trust

OTHER

Sponsor Role collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Medical Research Council

OTHER_GOV

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anoop D Shah, MRCP

Role: PRINCIPAL_INVESTIGATOR

University College, London

Harry Hemingway, FRCP

Role: STUDY_DIRECTOR

University College, London

References

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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.

Reference Type BACKGROUND
PMID: 23220717 (View on PubMed)

Shah AD, Denaxas S, Nicholas O, Hingorani AD, Hemingway H. Neutrophil Counts and Initial Presentation of 12 Cardiovascular Diseases: A CALIBER Cohort Study. J Am Coll Cardiol. 2017 Mar 7;69(9):1160-1169. doi: 10.1016/j.jacc.2016.12.022.

Reference Type DERIVED
PMID: 28254179 (View on PubMed)

Shah AD, Thornley S, Chung SC, Denaxas S, Jackson R, Hemingway H. White cell count in the normal range and short-term and long-term mortality: international comparisons of electronic health record cohorts in England and New Zealand. BMJ Open. 2017 Feb 17;7(2):e013100. doi: 10.1136/bmjopen-2016-013100.

Reference Type DERIVED
PMID: 28213596 (View on PubMed)

Shah AD, Denaxas S, Nicholas O, Hingorani AD, Hemingway H. Low eosinophil and low lymphocyte counts and the incidence of 12 cardiovascular diseases: a CALIBER cohort study. Open Heart. 2016 Sep 5;3(2):e000477. doi: 10.1136/openhrt-2016-000477. eCollection 2016.

Reference Type DERIVED
PMID: 27621833 (View on PubMed)

Related Links

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https://www.caliberresearch.org/

CALIBER web site and data portal

Other Identifiers

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0938/30/Z/10/Z

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RP-PG-0407-10314

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

086091/Z/08/Z

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CALIBER 13-15

Identifier Type: -

Identifier Source: org_study_id