Ethnicity and Onset of Cardiovascular Disease: A CALIBER Study

NCT ID: NCT02176174

Last Updated: 2017-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1068318 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-02-28

Brief Summary

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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

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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

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Abdominal Aortic Aneurysm Coronary Heart Disease Sudden Cardiac Death Intracerebral Haemorrhage Heart Failure Ischemic Stroke Myocardial Infarction Stroke Peripheral Arterial Disease Stable Angina Pectoris Subarachnoid Haemorrhage Transient Ischemic Attack Unstable Angina Cardiac Arrest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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White

Self-reported ethnic group of Black, using the United Kingdom Census categories, as recorded in electronic health records.

No interventions assigned to this group

Black

Self-reported ethnic group of Black, using the United Kingdom Census categories, as recorded in electronic health records.

No interventions assigned to this group

South Asian

Self-reported ethnic group of South Asian, using the United Kingdom Census categories, as recorded in electronic health records.

No interventions assigned to this group

Mixed/Other

Self-reported ethnic group of Mixed or other, using the United Kingdom Census categories, as recorded in electronic health records.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wellcome Trust

OTHER

Sponsor Role collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Julie George

Honorary Research Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie George, Phd

Role: PRINCIPAL_INVESTIGATOR

University College, London

Harry Hemingway, PhD

Role: STUDY_DIRECTOR

University College, London

References

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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.

Reference Type BACKGROUND
PMID: 23220717 (View on PubMed)

George 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.

Reference Type DERIVED
PMID: 28598987 (View on PubMed)

Related Links

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https://www.caliberresearch.org/

CALIBER web site and data portal

Other Identifiers

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086091/Z/08/Z

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RP-PG-0407-10314

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CALIBER 13-14

Identifier Type: -

Identifier Source: org_study_id

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