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

NCT ID: NCT02062021

Last Updated: 2015-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-06-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

No intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wellcome Trust

OTHER

Sponsor Role: collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Harry Hemingway

Professor of Epidemiology and Public Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University College London

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

13_01

Identifier Type: -

Identifier Source: org_study_id