Clinical trial NCT02176174: Ethnicity and Onset of Cardiovascular Disease: A CALIBER Study
Official title: Ethnicity and Incidence of Twelve Cardiovascular Diseases: A CALIBER Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Keywords: Ethnic group
Cardiovascular disease
Atherosclerosis
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: National Institute for Health Research, United Kingdom
name: London School of Hygiene and Tropical Medicine
First posted: 2014-06-26
Enrollment: 1068318
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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).

Eligibility criteria: 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

Primary outcomes:
measure: Initial presentation of cardiovascular disease
timeFrame: 10 years
Secondary outcomes:
measure: All cause mortality
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
affiliation: University College, London
name: Julie George, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: University College, London
name: Harry Hemingway, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.