Social Deprivation and Initial Presentation of 12 Cardiovascular Diseases: a CALIBER Study (IP4)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Wellcome Trust
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Harry Hemingway, University College, London
ClinicalTrials.gov Identifier:
NCT01937065
First received: July 2, 2013
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention
Abdominal Aortic Aneurysm
Coronary Heart Disease NOS
Unheralded Corronary Death
Intracerebral Haemorrhage
Heart Failure
Ischemic Stroke
Myocardial Infarction
Stroke
Peripheral Arterial Disease
Stable Angina Pectoris
Subarachnoid Haemorrhage
Transient Ischemic Attack
Unstable Angina
Cardiac Arrest, Sudden Cardiac Death
Other: No treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1937360
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No treatment Other: No 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).

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

1,93 million patients registered in Clinical Practice Research Datalink (CPRD) practices

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01937065

Locations
United Kingdom
University College London
London, United Kingdom, WC1E 7HN
Sponsors and Collaborators
University College, London
Wellcome Trust
National Institute for Health Research, United Kingdom
  More Information

Additional Information:
No publications provided

Responsible Party: Harry Hemingway, Professor, University College, London
ClinicalTrials.gov Identifier: NCT01937065     History of Changes
Other Study ID Numbers: 12_153R_IP4
Study First Received: July 2, 2013
Last Updated: September 3, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Hemorrhage
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Death
Aortic Aneurysm
Heart Arrest
Cardiovascular Diseases
Infarction
Heart Diseases
Ischemia
Stroke
Heart Failure
Subarachnoid Hemorrhage
Aortic Aneurysm, Abdominal
Peripheral Arterial Disease
Peripheral Vascular Diseases
Myocardial Infarction
Death, Sudden, Cardiac
Angina, Unstable
Cerebral Hemorrhage
Ischemic Attack, Transient
Angina Pectoris
Angina, Stable
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aneurysm
Aortic Diseases

ClinicalTrials.gov processed this record on September 16, 2014