Myocardial InfarctionNCT02062021
Understanding the Role of Autoimmune Disorders on the Initial Presentation of Cardiovascular Disease
An observational study of Myocardial Infarction and Ischemic Stroke, run by University College, London at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Ischemic Stroke, Stroke
- How many people
- 200,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients registered in Clinical Practice Research Datalink (CPRD) practices
Who may be able to join
- One year prior to study entry
- 18 years or older
- Recorded sex
- Free of symptomatic cardiovascular disease at entry
Who cannot join
- Prior cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocardial Infarction, Ischemic Stroke, Stroke, Subarachnoid Haemorrhage, Venous Thrombosis, Transient Ischemic Attack
- Being tested
- No intervention
- Medical subject headings
- Myocardial Infarction, Ischemic Stroke, Stroke, Subarachnoid Hemorrhage, Venous Thrombosis, Ischemic Attack, Transient, Angina, Stable, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate ratios for the associations between presence of autoimmune disorders and initial presentation of myocardial infarction
Associated studies:
overall, by sex, by age group
Measured: 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
Associated studies:
overall, by sex, by age group
Measured: 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
Associated studies:
overall, by sex, by age group
Measured: 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 outcomes (6)
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
Measured: 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
Associated studies:
overall, by sex, by age group
Measured: 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
Associated studies:
overall, by sex, by age group
Measured: 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
Associated studies:
overall, by sex, by age group
Measured: 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
Associated studies:
overall, by sex, by age group
Measured: 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
Associated studies:
overall, by sex, by age group
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Harry Hemingway, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062021
- Sponsor's protocol ID
- 13_01
- Status last verified
- Apr 2015
- First submitted
- 30 Jan 2014
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Role of Autoimmune Disorders on the Initial Presentation of Cardiovascular Disease: a CALIBER Proposal Using Linked GPRD-MINAP-HES Data
- ClinicalTrials.gov ID
- NCT02062021
- Acronym / sponsor ID
- 13_01
- Conditions
- Myocardial Infarction, Ischemic Stroke, Stroke, Subarachnoid Haemorrhage, Venous Thrombosis, Transient Ischemic Attack
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Wellcome Trust, National Institute for Health Research, United Kingdom
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (estimated)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients registered in Clinical Practice Research Datalink (CPRD) practices
Key inclusion criteria (4 listed)
- One year prior to study entry
- 18 years or older
- Recorded sex
- Free of symptomatic cardiovascular disease at entry
Key exclusion criteria (1 listed)
- Prior cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | – |
Primary outcome
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)
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)
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)
Associated studies: overall, by sex, by age group
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Ischemic Stroke, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.