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Ethnicity and Onset of Cardiovascular Disease: A CALIBER Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02176174
First Posted: June 26, 2014
Last Update Posted: June 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Wellcome Trust
National Institute for Health Research, United Kingdom
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Julie George, University College, London
  Purpose

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.


Condition
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 Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ethnicity and Incidence of Twelve Cardiovascular Diseases: A CALIBER Study

Resource links provided by NLM:


Further study details as provided by Julie George, University College, London:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • All cause mortality [ Time Frame: 10 years ]

Enrollment: 1068318
Actual Study Start Date: December 2013
Study Completion Date: February 2017
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176174


Sponsors and Collaborators
University College, London
Wellcome Trust
National Institute for Health Research, United Kingdom
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Julie George, Phd University College, London
Study Director: Harry Hemingway, PhD University College, London
  More Information

Additional Information:
Publications:
Responsible Party: Julie George, Honorary Research Associate, University College, London
ClinicalTrials.gov Identifier: NCT02176174     History of Changes
Other Study ID Numbers: CALIBER 13-14
086091/Z/08/Z ( Other Grant/Funding Number: Wellcome Trust )
RP-PG-0407-10314 ( Other Grant/Funding Number: National Institute for Health Research )
First Submitted: June 25, 2014
First Posted: June 26, 2014
Last Update Posted: June 8, 2017
Last Verified: June 2017

Keywords provided by Julie George, University College, London:
Ethnic group
Cardiovascular disease
Atherosclerosis

Additional relevant MeSH terms:
Stroke
Heart Failure
Ischemia
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Hemorrhage
Aneurysm
Angina Pectoris
Heart Arrest
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Aortic Aneurysm
Peripheral Arterial Disease
Peripheral Vascular Diseases
Subarachnoid Hemorrhage
Aortic Aneurysm, Abdominal
Angina, Stable
Cerebral Hemorrhage
Ischemic Attack, Transient
Death
Death, Sudden, Cardiac
Angina, Unstable
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases