Ethnicity and Onset of Cardiovascular Disease: A CALIBER Study

Stroke Clinical Trial

Official title:

Ethnicity and Incidence of Twelve Cardiovascular Diseases: A CALIBER Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02176174
• Other study ID #: CALIBER 13-14
• Secondary ID: 086091/Z/08/ZRP-
• Status: Completed
• Phase: N/A
• First received: June 25, 2014
• Last updated: June 7, 2017
• Start date: December 2013
• Est. completion date: February 2017

Study information

• Verified date: June 2017
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1068318
• Est. completion date: February 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Cardiac Arrest
• Cardiovascular Diseases
• Cerebral Hemorrhage
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Death
• Death, Sudden, Cardiac
• Heart Arrest
• Heart Diseases
• Heart Failure
• Hemorrhage
• Infarction
• Intracerebral Haemorrhage
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Myocardial Infarction
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Stable Angina Pectoris
• Stroke
• Subarachnoid Haemorrhage
• Subarachnoid Hemorrhage
• Sudden Cardiac Death
• Transient Ischemic Attack
• Unstable Angina

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University College, London	London School of Hygiene and Tropical Medicine, National Institute for Health Research, United Kingdom, Wellcome Trust

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All cause mortality		10 years

External Links

•   CALIBER web site and data portal