Ethnicity and Onset of Cardiovascular Disease: A CALIBER Study

This study is ongoing, but not recruiting participants.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT02176174
First received: June 25, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  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 University College, London:

Primary Outcome Measures:
  • Initial presentation of cardiovascular disease [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000000
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, RP-PG-0407-10314
Study First Received: June 25, 2014
Last Updated: June 25, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Aneurysm
Angina Pectoris
Angina, Unstable
Aortic Aneurysm
Cardiovascular Diseases
Ischemic Attack, Transient
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Arrest
Heart Diseases
Heart Failure
Hemorrhage
Infarction
Ischemia
Myocardial Infarction
Stroke
Cerebral Infarction
Subarachnoid Hemorrhage
Peripheral Arterial Disease
Peripheral Vascular Diseases
Death, Sudden, Cardiac
Aortic Aneurysm, Abdominal
Death
Cerebral Hemorrhage
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Aortic Diseases

ClinicalTrials.gov processed this record on July 22, 2014