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

Sponsor

University College, London (Other)

Overall Status

Unknown status

CT.gov ID

NCT02062021

Collaborator

Wellcome Trust (Other), National Institute for Health Research, United Kingdom (Other)

200,000

Enrollment

Location

Duration (Months)

11797.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Ischemic Stroke Stroke Subarachnoid Haemorrhage Venous Thrombosis Transient Ischemic Attack Stable Angina Pectoris Unstable Angina Heart Failure Peripheral Arterial Disease Abdominal Aortic Aneurysm	Other: No intervention

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 Design

Study Type:

Observational

Anticipated Enrollment :

200000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Jun 1, 2015

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Cumulative incidence per autoimmune disease status [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