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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Wellcome Trust
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Harry Hemingway, University College, London
ClinicalTrials.gov Identifier:
NCT02062021
First received: January 30, 2014
Last updated: February 11, 2014
Last verified: February 2014

January 30, 2014
February 11, 2014
January 2014
December 2014   (final data collection date for primary outcome 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) ] [ Designated as safety issue: No ]

    Associated studies:

    overall, by sex, by age group

  • 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) ] [ Designated as safety issue: No ]

    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 [ 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) ] [ Designated as safety issue: No ]

    Associated studies:

    overall, by sex, by age group

Same as current
Complete list of historical versions of study NCT02062021 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]

    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 [ 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) ] [ Designated as safety issue: No ]

    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 [ 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) ] [ Designated as safety issue: No ]

    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 [ 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) ] [ Designated as safety issue: No ]

    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 [ 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) ] [ Designated as safety issue: No ]

    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 [ 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) ] [ Designated as safety issue: No ]

    Associated studies:

    overall, by sex, by age group

Same as current
Cumulative incidence per autoimmune disease status [ 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) ] [ Designated as safety issue: No ]

Associations studied:

overall by sex by age group

Same as current
 
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Patients registered in Clinical Practice Research Datalink (CPRD) practices

  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200000
June 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT02062021
13_01
Yes
Harry Hemingway, University College, London
University College, London
  • Wellcome Trust
  • National Institute for Health Research, United Kingdom
Not Provided
University College, London
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP