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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT02014610
First received: December 12, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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.


Condition
Abdominal Aortic Aneurysm
Coronary Artery Disease
Stroke
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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).

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov 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
Investigators
Principal Investigator: Anoop D Shah, MRCP University College, London
Study Director: Harry Hemingway, FRCP University College, London
  More Information

Additional Information:
Publications:
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02014610     History of Changes
Other Study ID Numbers: CALIBER 13-15, 0938/30/Z/10/Z, RP-PG-0407-10314, 086091/Z/08/Z
Study First Received: December 12, 2013
Last Updated: December 12, 2013
Health Authority: UK: CALIBER Scientific Oversight Committee

Keywords provided by University College, London:
Neutrophil
Lymphocyte
Eosinophil
Leukocyte count
Cardiovascular disease
Atherosclerosis
Monocyte
Basophil

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Failure
Stroke
Peripheral Arterial Disease
Peripheral Vascular Diseases
Aortic Aneurysm, Abdominal
Vascular Diseases
Aortic Diseases
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Atherosclerosis

ClinicalTrials.gov processed this record on August 21, 2014