NCT02014610

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1997

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
16.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 18, 2013

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2013

Enrollment Period

16.9 years

First QC Date

December 12, 2013

Last Update Submit

December 12, 2013

Conditions

Abdominal Aortic AneurysmCoronary Artery DiseaseStrokeHeart FailurePeripheral Arterial Disease

Keywords

NeutrophilLymphocyteEosinophilLeukocyte countCardiovascular diseaseAtherosclerosisMonocyteBasophil

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • All cause mortality

    10 years

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All patients aged 30 and over, registered with a participating general practice during the study period.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 23220717BACKGROUND

  • 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.

    PMID: 28254179DERIVED

  • 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.

    PMID: 28213596DERIVED

  • 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.

    PMID: 27621833DERIVED

Related Links

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalCoronary Artery DiseaseStrokeHeart FailurePeripheral Arterial DiseaseCardiovascular DiseasesAtherosclerosis

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesAortic DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPeripheral Vascular Diseases

Study Officials

  • Anoop D Shah, MRCP

    University College, London

    PRINCIPAL INVESTIGATOR

  • Harry Hemingway, FRCP

    University College, London

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2013

First Posted

December 18, 2013

Study Start

January 1, 1997

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

December 18, 2013

Record last verified: 2013-12