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

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Brief Title

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

Official Title

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

Brief Summary

      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.

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.

Study Type

Observational

Primary Outcome

Rate ratios for the associations between presence of autoimmune disorders and initial presentation of myocardial infarction

Secondary Outcome

 Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of stable angina

Condition

Myocardial Infarction

Intervention

No intervention

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

200000

Start Date

January 2014

Completion Date

June 2015

Primary Completion Date

December 2014

Eligibility Criteria

        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

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, ,

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations

NCT ID

NCT02062021

Organization ID

13_01

Responsible Party

Principal Investigator

Study Sponsor

University College, London

Collaborators

 Wellcome Trust

Study Sponsor

, ,

Verification Date

April 2015