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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by University College, London.
Recruitment status was:  Active, not recruiting
Wellcome Trust
National Institute for Health Research, United Kingdom
Medical Research Council
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
University College, London Identifier:
First received: December 12, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted

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.

Abdominal Aortic Aneurysm
Coronary Artery Disease
Heart Failure
Peripheral Arterial Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Leukocyte Counts and Initial Presentation of Cardiovascular Diseases: a CALIBER Study

Resource links provided by NLM:

Further study details as provided by University College, London:

Primary Outcome Measures:
  • Initial presentation of cardiovascular disease [ Time Frame: 10 years ]
    First recorded diagnosis of cardiovascular disease during follow-up: ventricular arrhythmia / sudden cardiac death, heart failure, unheralded coronary death, myocardial infarction, unstable angina, stable angina, abdominal aortic aneurysm, peripheral arterial disease, subarachnoid haemorrhage, intracerebral haemorrhage, ischaemic stroke, transient ischaemic attack

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: 10 years ]

Estimated Enrollment: 800000
Study Start Date: January 1997
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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).


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
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 full blood count (complete blood count) 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.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02014610

Sponsors and Collaborators
University College, London
Wellcome Trust
National Institute for Health Research, United Kingdom
Medical Research Council
London School of Hygiene and Tropical Medicine
Principal Investigator: Anoop D Shah, MRCP University College, London
Study Director: Harry Hemingway, FRCP University College, London
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University College, London Identifier: NCT02014610     History of Changes
Other Study ID Numbers: CALIBER 13-15
0938/30/Z/10/Z ( Other Grant/Funding Number: Wellcome Trust )
RP-PG-0407-10314 ( Other Grant/Funding Number: UK National Institute for Health Research )
086091/Z/08/Z ( Other Grant/Funding Number: Wellcome Trust )
Study First Received: December 12, 2013
Last Updated: December 12, 2013

Keywords provided by University College, London:
Leukocyte count
Cardiovascular disease

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Aortic Aneurysm
Peripheral Arterial Disease
Peripheral Vascular Diseases
Aortic Aneurysm, Abdominal
Heart Diseases
Arterial Occlusive Diseases
Vascular Diseases
Aortic Diseases
Atherosclerosis processed this record on May 23, 2017