Clinical trial NCT02062021: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: National Institute for Health Research, United Kingdom
First posted: 2014-02-13
Enrollment: 200000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients registered in Clinical Practice Research Datalink (CPRD) practices

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.

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

Primary outcomes:
measure: Rate ratios for the associations between presence of autoimmune disorders and initial presentation of myocardial infarction
timeFrame: 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)
measure: Rate ratios for the associations between presence of autoimmune disorders and initial presentation of stroke
timeFrame: 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)
measure: Rate ratios for the associations between presence of autoimmune disorders and initial presentation of stroke and venous thrombosis
timeFrame: 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
timeFrame: 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)
measure: Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of unstable angina
timeFrame: 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)
measure: Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of heart failure
timeFrame: 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)
measure: Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of peripheral arterial disease
timeFrame: 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)
measure: Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of transient ischemic attack
timeFrame: 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)
measure: Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of abdominal aortic aneurysm
timeFrame: 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)
Other outcomes:
measure: Cumulative incidence per autoimmune disease status
timeFrame: 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)
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
References: