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
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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
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Verification Date
April 2015