Understanding the Role of Autoimmune Disorders on the Initial Presentation of Cardiovascular Disease

Overview

Autoimmune diseases are diseases in which inappropriate immune responses that have the capability of harming host cells play an important role. Evidence suggests that the presence of certain autoimmune diseases such as rheumatoid arthritis or systematic lupus erythematosus increase the risk of cardiovascular disease (CVD). However, this evidence is inconsistent for autoimmune disorders and no systematic approach has been previously used to study the relationship between a range of common autoimmune disorders and specific forms of cardiovascular diseases such as myocardial infarction, intracerebral and subarachnoid haemorrhage, or venous thrombosis. The investigators will use linked electronic health records to investigate whether commonly diagnosed autoimmune disorders are associated with increased risk of CVD development and whether effects differ in men and women and change with age.

Full Title of Study: “Understanding the Role of Autoimmune Disorders on the Initial Presentation of Cardiovascular Disease: a CALIBER Proposal Using Linked GPRD-MINAP-HES Data”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 2014

Detailed Description

The linkage of Clinical Practice Research Datalink (CPRD) to the national registry of acute coronary syndromes (the Myocardial Ischaemia National Audit Project, MINAP), Hospital Episode Statistics (HES) and Office for National Statistics (ONS) available through CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records), offers an opportunity to investigate the association between autoimmune disorders and the initial presentation of non-fatal and fatal specific cardiovascular phenotypes. The use of a systematic approach to investigate whether a range of commonly diagnosed autoimmune disorders are independent risk factors for several specific and well defined arterial and venous diseases will help to improve the investigators understanding of the role of autoimmune disorders in development of specific types of CVD in both men and women and in different age groups. It will also provide useful information to improve existing cardiovascular risk prediction methods that are used in clinical practice for patient management.

Interventions

  • Other: No intervention

Clinical Trial Outcome Measures

Primary Measures

  • Rate ratios for the associations between presence of autoimmune disorders and initial presentation of myocardial infarction
    • Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)
    • Associated studies: overall, by sex, by age group
  • Rate ratios for the associations between presence of autoimmune disorders and initial presentation of stroke
    • Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)
    • Associated studies: overall, by sex, by age group
  • Rate ratios for the associations between presence of autoimmune disorders and initial presentation of stroke and venous thrombosis
    • Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)
    • Associated studies: overall, by sex, by age group

Secondary Measures

  • Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of stable angina
    • Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)
    • Associations studied: overall by sex by age group
  • Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of unstable angina
    • Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)
    • Associated studies: overall, by sex, by age group
  • Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of heart failure
    • Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)
    • Associated studies: overall, by sex, by age group
  • Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of peripheral arterial disease
    • Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)
    • Associated studies: overall, by sex, by age group
  • Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of transient ischemic attack
    • Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)
    • Associated studies: overall, by sex, by age group
  • Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of abdominal aortic aneurysm
    • Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)
    • Associated studies: overall, by sex, by age group

Participating in This Clinical Trial

Inclusion Criteria

  • One year prior to study entry – 18 years or older – Recorded sex – Free of symptomatic cardiovascular disease at entry Exclusion Criteria:

  • Prior cardiovascular disease

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University College, London
  • Collaborator
    • Wellcome Trust
  • Provider of Information About this Clinical Study
    • Principal Investigator: Harry Hemingway, Professor of Epidemiology and Public Health – University College, London

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