Overview

This trial is active, not recruiting.

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
Sponsor University College, London
Collaborator Wellcome Trust
Start date December 2013
End date August 2016
Trial size 1000000 participants
Trial identifier NCT02176174, 086091/Z/08/Z, CALIBER 13-14, RP-PG-0407-10314

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Self-reported ethnic group of Black, using the United Kingdom Census categories, as recorded in electronic health records.
Self-reported ethnic group of Black, using the United Kingdom Census categories, as recorded in electronic health records.
Self-reported ethnic group of South Asian, using the United Kingdom Census categories, as recorded in electronic health records.
Self-reported ethnic group of Mixed or other, using the United Kingdom Census categories, as recorded in electronic health records.

Primary Outcomes

Measure
Initial presentation of cardiovascular disease
time frame: 10 years

Secondary Outcomes

Measure
All cause mortality
time frame: 10 years

Eligibility Criteria

Male or female participants at least 30 years old.

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

Additional Information

Official title Ethnicity and Incidence of Twelve Cardiovascular Diseases: A CALIBER Study
Principal investigator Julie George, Phd
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).
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University College, London.