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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02062021
Enrollment
200000
Registered
2014-02-13
Start date
2014-01-31
Completion date
2015-06-30
Last updated
2015-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm, Heart Failure, Ischemic Stroke, Myocardial Infarction, Peripheral Arterial Disease, Stable Angina Pectoris, Stroke, Subarachnoid Haemorrhage, Transient Ischemic Attack, Unstable Angina, Venous Thrombosis

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.

Interventions

OTHERNo intervention

Sponsors

Wellcome Trust
CollaboratorOTHER
National Institute for Health Research, United Kingdom
CollaboratorOTHER_GOV
University College, London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rate ratios for the associations between presence of autoimmune disorders and initial presentation of stroke and venous thrombosisFollowed 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 myocardial infarctionFollowed 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 strokeFollowed 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

MeasureTime frameDescription
Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of heart failureFollowed 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 diseaseFollowed 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 aneurysmFollowed 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 attackFollowed 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 unstable anginaFollowed 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 stable anginaFollowed 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

Other

MeasureTime frameDescription
Cumulative incidence per autoimmune disease statusFollowed 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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026