- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01937065
Social Deprivation and Initial Presentation of 12 Cardiovascular Diseases: a CALIBER Study (IP4)
September 3, 2013 updated by: Harry Hemingway, University College, London
Study of heterogeneity in associations between social deprivation and the initial presentation of 12 cardiovascular diseases.
Study Overview
Status
Unknown
Conditions
- Myocardial Infarction
- Heart Failure
- Stroke
- Ischemic Stroke
- Peripheral Arterial Disease
- Transient Ischemic Attack
- Stable Angina Pectoris
- Unstable Angina
- Abdominal Aortic Aneurysm
- Intracerebral Haemorrhage
- Subarachnoid Haemorrhage
- Coronary Heart Disease NOS
- Unheralded Corronary Death
- Cardiac Arrest, Sudden Cardiac Death
Intervention / Treatment
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).
Study Type
Observational
Enrollment (Actual)
1937360
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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-
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London, United Kingdom, WC1E 7HN
- 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
28 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
1,93 million patients registered in Clinical Practice Research Datalink (CPRD) practices
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Pregnant women in the 6 months before the eligibility date
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
No treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hazard ratios for the associations between social deprivation and initial presentation of 12 cardiovascular diseases.
Time Frame: Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years
|
Associations studied:
|
Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lifetime cumulative incidence per quintile of social deprivation
Time Frame: Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years
|
Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heterogeneity in associations across 12 cardiovascular diseases using the Tau-squared statistic and I-square statistics.
Time Frame: Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years
|
Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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, 2012
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
July 2, 2013
First Submitted That Met QC Criteria
September 3, 2013
First Posted (Estimate)
September 9, 2013
Study Record Updates
Last Update Posted (Estimate)
September 9, 2013
Last Update Submitted That Met QC Criteria
September 3, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pain
- Neurologic Manifestations
- Atherosclerosis
- Death, Sudden
- Brain Ischemia
- Infarction
- Intracranial Hemorrhages
- Chest Pain
- Aneurysm
- Aortic Diseases
- Heart Arrest
- Myocardial Infarction
- Heart Diseases
- Stroke
- Coronary Disease
- Ischemic Stroke
- Ischemia
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Death
- Ischemic Attack, Transient
- Hemorrhage
- Subarachnoid Hemorrhage
- Cerebral Hemorrhage
- Angina Pectoris
- Angina, Stable
- Angina, Unstable
- Aortic Aneurysm
- Aortic Aneurysm, Abdominal
- Death, Sudden, Cardiac
Other Study ID Numbers
- 12_153R_IP4
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.
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