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
  Purpose

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.


Condition Intervention
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Understanding the Role of Autoimmune Disorders on the Initial Presentation of Cardiovascular Disease: a CALIBER Proposal Using Linked GPRD-MINAP-HES Data

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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



Other Outcome Measures:
  • 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



Estimated Enrollment: 200000
Study Start Date: January 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients registered in Clinical Practice Research Datalink (CPRD) practices

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02062021

Locations
United Kingdom
University College London
London, United Kingdom
Sponsors and Collaborators
University College, London
Wellcome Trust
National Institute for Health Research, United Kingdom
  More Information

No publications provided

Responsible Party: Harry Hemingway, Professor of Epidemiology and Public Health, University College, London
ClinicalTrials.gov Identifier: NCT02062021     History of Changes
Other Study ID Numbers: 13_01
Study First Received: January 30, 2014
Last Updated: February 11, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Autoimmune Diseases
Angina Pectoris
Angina, Stable
Angina, Unstable
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Cardiovascular Diseases
Heart Failure
Hemorrhage
Infarction
Ischemia
Ischemic Attack, Transient
Myocardial Infarction
Peripheral Arterial Disease
Peripheral Vascular Diseases
Stroke
Subarachnoid Hemorrhage
Thrombosis
Venous Thromboembolism
Venous Thrombosis
Aneurysm
Aortic Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Brain Diseases
Brain Ischemia
Central Nervous System Diseases
Cerebrovascular Disorders
Chest Pain

ClinicalTrials.gov processed this record on October 30, 2014