- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02014610
White Blood Cell Counts and Onset of Cardiovascular Diseases: a CALIBER Study (CALIBER)
Leukocyte Counts and Initial Presentation of Cardiovascular Diseases: a CALIBER Study
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.
Study Overview
Status
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).
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All cause mortality
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anoop D Shah, MRCP, University College, London
Publications and helpful links
General Publications
- 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.
- 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. Erratum In: J Am Coll Cardiol. 2017 Jun 27;69(25):3125-3126.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Atherosclerosis
- Coronary Disease
- Aortic Diseases
- Coronary Artery Disease
- Cardiovascular Diseases
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Aneurysm
- Aortic Aneurysm
- Aortic Aneurysm, Abdominal
Other Study ID Numbers
- CALIBER 13-15
- RP-PG-0407-10314 (Other Grant/Funding Number: Wellcome Trust)
- 086091/Z/08/Z (Other Grant/Funding Number: Wellcome Trust)
- 0938/30/Z/10/Z (Other Grant/Funding Number: Wellcome Trust)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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