Abdominal Aortic AneurysmCALIBERNCT02014610
White Blood Cell Counts and Onset of Cardiovascular Diseases: a CALIBER Study
An observational study of Abdominal Aortic Aneurysm and Coronary Artery Disease, run by University College, London.
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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Aortic Aneurysm, Coronary Artery Disease, Stroke
- How many people
- 800,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 1997to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- All patients aged 30 and over, registered with a participating general practice during the study period.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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).
- Conditions
- Abdominal Aortic Aneurysm, Coronary Artery Disease, Stroke, Heart Failure, Peripheral Arterial Disease
- Keywords
- Neutrophil, Lymphocyte, Eosinophil, Leukocyte count, Cardiovascular disease, Atherosclerosis, Monocyte, Basophil
- Medical subject headings
- Aortic Aneurysm, Abdominal, Coronary Artery Disease, Stroke, Heart Failure, Peripheral Arterial Disease, Cardiovascular Diseases, Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Secondary outcomes (1)
All cause mortality
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startJan 1997
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, National Institute for Health Research, United Kingdom, Medical Research Council, London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- Anoop D Shah, MRCP, Principal investigator, University College, LondonHarry Hemingway, FRCP, Study director, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014610
- Sponsor's protocol ID
- CALIBER 13-15
- Other IDs
- 0938/30/Z/10/Z, RP-PG-0407-10314, 086091/Z/08/Z
- Acronym
- CALIBER
- Status last verified
- Dec 2013
- First submitted
- 12 Dec 2013
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 23220717Shah 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.
PubMed 28254179Shah 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.
PubMed 28213596Shah 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.
PubMed 27621833
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leukocyte Counts and Initial Presentation of Cardiovascular Diseases: a CALIBER Study
- ClinicalTrials.gov ID
- NCT02014610
- Acronym / sponsor ID
- CALIBER / CALIBER 13-15
- Conditions
- Abdominal Aortic Aneurysm, Coronary Artery Disease, Stroke, Heart Failure, Peripheral Arterial Disease
- Keywords
- Neutrophil, Lymphocyte, Eosinophil, Leukocyte count, Cardiovascular disease, Atherosclerosis, Monocyte, Basophil
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800,000 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Wellcome Trust, National Institute for Health Research, United Kingdom, Medical Research Council, London School of Hygiene and Tropical Medicine
- Study start
- Jan 1997
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 18 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients aged 30 and over, registered with a participating general practice during the study period.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
All cause mortality
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Background: PubMed 23220717Denaxas 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.
- Derived from this study: PubMed 28254179Shah 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.
- Derived from this study: PubMed 28213596Shah 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.
- Derived from this study: PubMed 27621833Shah 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.
- CALIBER web site and data portalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anoop D Shah, MRCP principal investigator
University College, London
Harry Hemingway, FRCP study director
University College, London
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm and Coronary Artery Disease, run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial presentation of cardiovascular disease (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02014610, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.