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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01937065
Other study ID # 12_153R_IP4
Secondary ID
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
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