Abdominal Aortic AneurysmIP4NCT01937065
Social Deprivation and Initial Presentation of 12 Cardiovascular Diseases: a CALIBER Study
An observational study of Abdominal Aortic Aneurysm and Coronary Heart Disease NOS, run by University College, London at 1 site in United Kingdom.
Trial summary
Study of heterogeneity in associations between social deprivation and the initial presentation of 12 cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Aortic Aneurysm, Coronary Heart Disease NOS, Unheralded Corronary Death
- What is being tested?
- No treatment
- How many people
- 1,937,360 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Dec 2014
- Phase
- Observational
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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1,93 million patients registered in Clinical Practice Research Datalink (CPRD) practices
Who may be able to join
- One year prior to study entry (up-to-standard follow-up, CPRD quality research standard).
- 30 years or older
- Recorded sex
- Free of symptomatic CVD at inclusion.
Who cannot join
- Pregnant women in the 6 months before the eligibility date
Trial locations and contacts
1 site in 1 country.
About this study
Study of heterogeneity in associations between social deprivation and the initial presentation of 12 cardiovascular diseases.
Read the detailed description
This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).
- Conditions
- Abdominal Aortic Aneurysm, Coronary Heart Disease NOS, Unheralded Corronary Death, Intracerebral Haemorrhage, Heart Failure, Ischemic Stroke
- Being tested
- No treatment
- Medical subject headings
- Aortic Aneurysm, Abdominal, Cerebral Hemorrhage, Heart Failure, Ischemic Stroke, Myocardial Infarction, Stroke, Peripheral Arterial Disease, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Not described Receives: Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hazard ratios for the associations between social deprivation and initial presentation of 12 cardiovascular diseases.
Associations studied:
- overall
- by sex
- by age group
- in high risk groups (smokers, hypertensive disease, obese, diabetic, depression)
- before and after the introduction of the Quality and Outcomes Framework in England
Measured: Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years
Secondary outcomes (1)
Lifetime cumulative incidence per quintile of social deprivation
Measured: Followed for the duration of general practice registration between January 1997 and March 2010, an expected average 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 posted9 Sep 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies 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
- 1,937,360 participants (actual)
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
- NCT01937065
- Sponsor's protocol ID
- 12_153R_IP4
- Acronym
- IP4
- Status last verified
- Sep 2013
- First submitted
- 2 Jul 2013
- Last updated
- 9 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes