Overview

This trial is active, not recruiting.

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
Treatment no intervention
Sponsor University College, London
Collaborator Wellcome Trust
Start date January 2014
End date December 2014
Trial size 200000 participants
Trial identifier NCT02062021, 13_01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective

Primary Outcomes

Measure
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)
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)
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)

Secondary Outcomes

Measure
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)
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)
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)
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)
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)
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)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Understanding the Role of Autoimmune Disorders on the Initial Presentation of Cardiovascular Disease: a CALIBER Proposal Using Linked GPRD-MINAP-HES Data
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University College, London.