Abdominal Aortic AneurysmNCT02176174
Ethnicity and Onset of Cardiovascular Disease: A CALIBER Study
An observational study of Abdominal Aortic Aneurysm and Coronary Heart Disease, run by University College, London.
Trial summary
Specific cardiovascular diseases, such as stroke and heart attack, have been shown to vary by ethnic group. However, less is known about differences between ethnic groups and a wider range of cardiovascular diseases. 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 Heart Disease, Sudden Cardiac Death
- How many people
- 1,068,318 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Feb 2017
- 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: Patients in the CALIBER database who have a record of ethnic group 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
- Patients aged 30 and over
- Registered with a participating general practice during the study period
- Minimum one year of records prior to study entry meeting CPRD data quality
Who cannot join
- Patients without a record of ethnic group
- Patients without record of gender
- Patients with prior atherosclerotic disease, as recorded in primary care or hospitalisation data
- Pregnant women in the 6 months before the eligibility date
About this study
Official title: Ethnicity and Incidence of Twelve Cardiovascular Diseases: A CALIBER Study
Specific cardiovascular diseases, such as stroke and heart attack, have been shown to vary by ethnic group. However, less is known about differences between ethnic groups and a wider range of cardiovascular diseases. This study will examine differences between ethnic groups (White, Black, South Asian and Mixed/Other) and first lifetime presentation of twelve different cardiovascular diseases. This information may help to predict the onset of cardiovascular diseases and inform disease prevention strategies.
The hypothesis is that different ethnic groups have differing associations with the range of cardiovascular diseases studied.
Read the detailed description
There is evidence from epidemiological studies that different ethnic groups are associated with increased incidence of specific cardiovascular diseases. However, the majority of existing studies have examined associations with one or two acute conditions such as stroke or coronary heart disease or focused on a particular ethnic group.
The aim of this study is to examine the differing associations between four ethnic groups and the initial lifetime presentation of a broad range of cardiovascular diseases, including chronic presentations such as stable angina. The hypothesis is that there will be heterogeneity of associations between the different ethnic groups and the full range of cardiovascular diseases studied.
The study will use data from the CALIBER data set of clinically collected electronic health record data from England.
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 - CPRD) 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 data set).
- Conditions
- Abdominal Aortic Aneurysm, Coronary Heart Disease, Sudden Cardiac Death, Intracerebral Haemorrhage, Heart Failure, Ischemic Stroke
- Keywords
- Ethnic group, Cardiovascular disease, Atherosclerosis
- Medical subject headings
- Aortic Aneurysm, Abdominal, Coronary Disease, Death, Sudden, Cardiac, Cerebral Hemorrhage, Heart Failure, Ischemic Stroke, Myocardial Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| White | Self-reported ethnic group of Black, using the United Kingdom Census categories, as recorded in electronic health records. | |
| Black | Self-reported ethnic group of Black, using the United Kingdom Census categories, as recorded in electronic health records. | |
| South Asian | Self-reported ethnic group of South Asian, using the United Kingdom Census categories, as recorded in electronic health records. | |
| Mixed/Other | Self-reported ethnic group of Mixed or other, using the United Kingdom Census categories, as recorded in electronic health records. |
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 posted26 Jun 2014 (estimated)
- Study startDec 2013
- Primary completionAug 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 1,068,318 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, National Institute for Health Research, United Kingdom, London School of Hygiene and Tropical Medicine
- Responsible party
- Principal investigator, Julie George, University College, London
- Investigators
- Julie George, Phd, Principal investigator, University College, LondonHarry Hemingway, PhD, Study director, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176174
- Sponsor's protocol ID
- CALIBER 13-14
- Other IDs
- 086091/Z/08/Z, RP-PG-0407-10314
- Status last verified
- Jun 2017
- First submitted
- 25 Jun 2014
- Last updated
- 8 Jun 2017
- 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 23220717George J, Mathur R, Shah AD, Pujades-Rodriguez M, Denaxas S, Smeeth L, Timmis A, Hemingway H. Ethnicity and the first diagnosis of a wide range of cardiovascular diseases: Associations in a linked electronic health record cohort of 1 million patients. PLoS One. 2017 Jun 9;12(6):e0178945. doi: 10.1371/journal.pone.0178945. eCollection 2017.
PubMed 28598987
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethnicity and Incidence of Twelve Cardiovascular Diseases: A CALIBER Study
- ClinicalTrials.gov ID
- NCT02176174
- Acronym / sponsor ID
- CALIBER 13-14
- Conditions
- Abdominal Aortic Aneurysm, Coronary Heart Disease, Sudden Cardiac Death, Intracerebral Haemorrhage, Heart Failure, Ischemic Stroke
- Keywords
- Ethnic group, Cardiovascular disease, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,068,318 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Wellcome Trust, National Institute for Health Research, United Kingdom, London School of Hygiene and Tropical Medicine
- Study start
- Dec 2013 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 26 Jun 2014 (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.
Specific cardiovascular diseases, such as stroke and heart attack, have been shown to vary by ethnic group. However, less is known about differences between ethnic groups and a wider range of cardiovascular diseases. This study will examine differences between ethnic groups (White, Black, South Asian and Mixed/Other) and first lifetime presentation of twelve different cardiovascular diseases. This information may help to predict the onset of cardiovascular diseases and inform disease prevention strategies.
The hypothesis is that different ethnic groups have differing associations with the range of cardiovascular diseases studied.
Detailed description
There is evidence from epidemiological studies that different ethnic groups are associated with increased incidence of specific cardiovascular diseases. However, the majority of existing studies have examined associations with one or two acute conditions such as stroke or coronary heart disease or focused on a particular ethnic group.
The aim of this study is to examine the differing associations between four ethnic groups and the initial lifetime presentation of a broad range of cardiovascular diseases, including chronic presentations such as stable angina. The hypothesis is that there will be heterogeneity of associations between the different ethnic groups and the full range of cardiovascular diseases studied.
The study will use data from the CALIBER data set of clinically collected electronic health record data from England.
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 - CPRD) 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 data set).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| White | – | –Self-reported ethnic group of Black, using the United Kingdom Census categories, as recorded in electronic health records. |
| Black | – | –Self-reported ethnic group of Black, using the United Kingdom Census categories, as recorded in electronic health records. |
| South Asian | – | –Self-reported ethnic group of South Asian, using the United Kingdom Census categories, as recorded in electronic health records. |
| Mixed/Other | – | –Self-reported ethnic group of Mixed or other, using the United Kingdom Census categories, as recorded in electronic health records. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the CALIBER database who have a record of ethnic group 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 (3 listed)
- Patients aged 30 and over
- Registered with a participating general practice during the study period
- Minimum one year of records prior to study entry meeting CPRD data quality
Key exclusion criteria (4 listed)
- Patients without a record of ethnic group
- Patients without record of gender
- Patients with prior atherosclerotic disease, as recorded in primary care or hospitalisation data
- Pregnant women in the 6 months before the eligibility date
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- 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 28598987George J, Mathur R, Shah AD, Pujades-Rodriguez M, Denaxas S, Smeeth L, Timmis A, Hemingway H. Ethnicity and the first diagnosis of a wide range of cardiovascular diseases: Associations in a linked electronic health record cohort of 1 million patients. PLoS One. 2017 Jun 9;12(6):e0178945. doi: 10.1371/journal.pone.0178945. eCollection 2017.
- 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.
Julie George, Phd principal investigator
University College, London
Harry Hemingway, PhD study director
University College, London
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm and Coronary Heart 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 8 Jun 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NCT02176174, which also lists 2 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 8 Jun 2017.