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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02062021
• Other study ID #: 13_01
• Status: Active, not recruiting
• Phase: N/A
• First received: January 30, 2014
• Last updated: April 20, 2015
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: April 2015
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200000
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Autoimmune Diseases
• Cardiovascular Diseases
• Heart Failure
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Myocardial Infarction
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Stable Angina Pectoris
• Stroke
• Subarachnoid Haemorrhage
• Subarachnoid Hemorrhage
• Transient Ischemic Attack
• Unstable Angina
• Venous Thrombosis

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
United Kingdom	University College London	London

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	National Institute for Health Research, United Kingdom, Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cumulative incidence per autoimmune disease status	Associations studied: overall by sex by age group	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)	No
Primary	Rate ratios for the associations between presence of autoimmune disorders and initial presentation of myocardial infarction	Associated studies: overall, by sex, by age group	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)	No
Primary	Rate ratios for the associations between presence of autoimmune disorders and initial presentation of stroke	Associated studies: overall, by sex, by age group	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)	No
Primary	Rate ratios for the associations between presence of autoimmune disorders and initial presentation of stroke and venous thrombosis	Associated studies: overall, by sex, by age group	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)	No
Secondary	Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of stable angina	Associations studied: overall by sex by age group	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)	No
Secondary	Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of unstable angina	Associated studies: overall, by sex, by age group	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)	No
Secondary	Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of heart failure	Associated studies: overall, by sex, by age group	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)	No
Secondary	Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of peripheral arterial disease	Associated studies: overall, by sex, by age group	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)	No
Secondary	Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of transient ischemic attack	Associated studies: overall, by sex, by age group	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)	No
Secondary	Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of abdominal aortic aneurysm	Associated studies: overall, by sex, by age group	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)	No