White Blood Cell Counts and Onset of Cardiovascular Diseases: a CALIBER Study (CALIBER)
|ClinicalTrials.gov Identifier: NCT02014610|
Recruitment Status : Unknown
Verified December 2013 by University College, London.
Recruitment status was: Active, not recruiting
First Posted : December 18, 2013
Last Update Posted : December 18, 2013
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 or disease|
|Abdominal Aortic Aneurysm Coronary Artery Disease Stroke Heart Failure Peripheral Arterial Disease|
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|
|Estimated Enrollment :||800000 participants|
|Official Title:||Leukocyte Counts and Initial Presentation of Cardiovascular Diseases: a CALIBER Study|
|Study Start Date :||January 1997|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2014|
- 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
- All cause mortality [ Time Frame: 10 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014610
|Principal Investigator:||Anoop D Shah, MRCP||University College, London|
|Study Director:||Harry Hemingway, FRCP||University College, London|