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

Stroke Clinical Trial

— CALIBER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02014610
• Other study ID #: CALIBER 13-15
• Secondary ID: 0938/30/Z/10/ZRP
• Status: Active, not recruiting
• Phase: N/A
• First received: December 12, 2013
• Last updated: December 12, 2013
• Start date: January 1997
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: UK: CALIBER Scientific Oversight Committee
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800000
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University College, London	London School of Hygiene and Tropical Medicine, Medical Research Council, National Institute for Health Research, United Kingdom, Wellcome Trust

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial presentation of cardiovascular disease	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	10 years	No
Secondary	All cause mortality		10 years	No

External Links

•   CALIBER web site and data portal