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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by Harry Hemingway, University College, London.
Recruitment status was:  Active, not recruiting
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 Harry Hemingway, 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 ]

    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 ]

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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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:
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

Additional relevant MeSH terms:
Stroke
Heart Failure
Infarction
Ischemia
Heart Diseases
Myocardial Infarction
Hemorrhage
Aneurysm
Angina Pectoris
Death
Heart Arrest
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Aortic Aneurysm
Peripheral Arterial Disease
Peripheral Vascular Diseases
Subarachnoid Hemorrhage
Aortic Aneurysm, Abdominal
Angina, Stable
Cerebral Hemorrhage
Ischemic Attack, Transient
Angina, Unstable
Death, Sudden, Cardiac
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2017