Understanding the Role of Autoimmune Disorders on the Initial Presentation of Cardiovascular Disease
April 20, 2015 updated by: Harry Hemingway, University College, London
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
200000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom
- University College London
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients registered in Clinical Practice Research Datalink (CPRD) practices
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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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)
|
|
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)
|
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)
|
|
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)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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)
|
|
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)
|
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)
|
|
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)
|
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)
|
|
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)
|
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)
|
|
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)
|
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)
|
|
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)
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Anticipated)
June 1, 2015
Study Registration Dates
First Submitted
January 30, 2014
First Submitted That Met QC Criteria
February 11, 2014
First Posted (Estimate)
February 13, 2014
Study Record Updates
Last Update Posted (Estimate)
April 21, 2015
Last Update Submitted That Met QC Criteria
April 20, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pain
- Neurologic Manifestations
- Embolism and Thrombosis
- Atherosclerosis
- Brain Ischemia
- Infarction
- Intracranial Hemorrhages
- Chest Pain
- Aneurysm
- Aortic Diseases
- Myocardial Infarction
- Stroke
- Cardiovascular Diseases
- Ischemic Stroke
- Ischemia
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Ischemic Attack, Transient
- Hemorrhage
- Thrombosis
- Venous Thrombosis
- Subarachnoid Hemorrhage
- Angina Pectoris
- Angina, Stable
- Autoimmune Diseases
- Angina, Unstable
- Aortic Aneurysm
- Aortic Aneurysm, Abdominal
Other Study ID Numbers
- 13_01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.