NCT02176174

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,068,318

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

June 8, 2017

Status Verified

June 1, 2017

Enrollment Period

2.7 years

First QC Date

June 25, 2014

Last Update Submit

June 7, 2017

Conditions

Keywords

Ethnic groupCardiovascular diseaseAtherosclerosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • All cause mortality

    10 years

Study Arms (4)

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.

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 23220717BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalCoronary DiseaseDeath, Sudden, CardiacCerebral HemorrhageHeart FailureIschemic StrokeMyocardial InfarctionStrokePeripheral Arterial DiseaseAngina, StableSubarachnoid HemorrhageIschemic Attack, TransientAngina, UnstableHeart ArrestCardiovascular DiseasesAtherosclerosis

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesAortic DiseasesMyocardial IschemiaHeart DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHemorrhageInfarctionIschemiaNecrosisArteriosclerosisArterial Occlusive DiseasesPeripheral Vascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsBrain Ischemia

Study Officials

  • Julie George, Phd

    University College, London

    PRINCIPAL INVESTIGATOR
  • Harry Hemingway, PhD

    University College, London

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Research Associate

Study Record Dates

First Submitted

June 25, 2014

First Posted

June 26, 2014

Study Start

December 1, 2013

Primary Completion

August 1, 2016

Study Completion

February 1, 2017

Last Updated

June 8, 2017

Record last verified: 2017-06