跳至主要内容
临床试验/NCT02062021
NCT02062021Unknown不适用

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

University College, London1 个研究点 分布在 1 个国家目标入组 200,000 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200,000
试验地点
1
主要终点
Rate ratios for the associations between presence of autoimmune disorders and initial presentation of stroke

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • One year prior to study entry
  • 18 years or older
  • Recorded sex
  • Free of symptomatic cardiovascular disease at entry

排除标准

  • Prior cardiovascular disease

结局指标

主要结局

Rate ratios for the associations between presence of autoimmune disorders and initial presentation of stroke

时间窗: 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)

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

时间窗: 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)

Associated studies: overall, by sex, by age group

Rate ratios for the associations between presence of autoimmune disorders and initial presentation of myocardial infarction

时间窗: 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)

Associated studies: overall, by sex, by age group

次要结局

  • Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of unstable angina(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(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 stable angina(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(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(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(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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Harry Hemingway

Professor of Epidemiology and Public Health

University College, London

研究点 (1)

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