Social Deprivation and Initial Presentation of 12 Cardiovascular Diseases: a CALIBER Study

Stroke Clinical Trial

— IP4  

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01937065
• Other study ID #: 12_153R_IP4
• Status: Active, not recruiting
• Phase: N/A
• First received: July 2, 2013
• Last updated: September 3, 2013
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: September 2013
• 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

Study of heterogeneity in associations between social deprivation and the initial presentation of 12 cardiovascular diseases.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1937360
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 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
• Cardiac Arrest, Sudden Cardiac Death
• Cerebral Hemorrhage
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease NOS
• Death
• Death, Sudden, Cardiac
• Heart Arrest
• Heart Diseases
• Heart Failure
• Hemorrhage
• Intracerebral Haemorrhage
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Myocardial Infarction
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Stable Angina Pectoris
• Stroke
• Subarachnoid Haemorrhage
• Subarachnoid Hemorrhage
• Transient Ischemic Attack
• Unheralded Corronary Death
• Unstable Angina

Intervention

Other:
• No treatment

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	Heterogeneity in associations across 12 cardiovascular diseases using the Tau-squared statistic and I-square statistics.		Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years	No
Primary	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	Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years	No
Secondary	Lifetime cumulative incidence per quintile of social deprivation		Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years	No

External Links

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