The Role of Alcohol Consumption in the Aetiology of Different Cardiovascular Disease Phenotypes: a CALIBER Study
NCT ID: NCT01864031
Last Updated: 2013-05-29
Study Results
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Basic Information
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UNKNOWN
2240000 participants
OBSERVATIONAL
1997-01-31
2014-12-31
Brief Summary
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Detailed Description
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As the focus of our research question is the effect of alcohol consumption on specific cardiovascular phenotypes we will not derive a single primary outcome. Utilising the strengths of the CALIBER data platform we will define multiple cardiovascular disease outcomes including: chronic stable angina (SA), unstable angina (UA), coronary heart disease not otherwise specified (CHD, NOS), acute myocardial infarction (MI), heart failure (HF), ventricular arrhythmias including cardiac arrest, abdominal aortic aneurysm (AAA), peripheral arterial disease (PAD), ischaemic and haemorrhagic (subarachnoid and intracerebral) strokes, transient ischaemic attack (TIA), and sudden cardiac death (SCD) or unheralded coronary death (UCD). Additionally non-CVD mortality will be defined as a competing outcome. These outcomes are defined/validated using multiple sources; including a combination of symptoms, diagnoses (including the use of additional information from ECG findings and troponin values) and prescriptions.
For comparison purposes (to major studies/existing consortia) we will also estimate models for aggregated CHD (MI and unheralded coronary death), CVD (CHD and stroke of any type) and fatal CVD (combination of fatal CHD and fatal CVD) endpoints.
Secondary outcomes: To examine whether the association between drinking categories and specific MI phenotypes differ we will rerun our models in patients who remained in the cohort from January 2003, when information from MINAP became available. This will allow for the composite MI category to be decomposed into ST elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (nSTEMI) and myocardial infarction not otherwise specified (MI NOS).
In light of current debates on the U/J-shaped relationship observed between alcohol consumption and aggregated CVD outcomes five drinking categories have been defined including: (1) Never drinkers ("tee-total" and "non-drinkers"), former drinkers (those with codes for "stopped drinking alcohol" and/or "ex-drinker"), occasional drinkers (those with codes for "drinks rarely" and/or "drinks occasionally"), current moderate drinkers (those who had a code for current alcohol consumer and an indicator of whether they drank within daily \[4/3 UK units of alcohol for men and women respectively\] and weekly \[21/14 UK units for men and women respectively\] recommended sensible drinking limits) and current heavy drinkers (defined as those who exceeded daily or weekly sensible drinking limits). Unfortunately information on binge drinking was only available for a select minority of the cohort (\~100 people) therefore a separate category for this drinking behaviour was not defined (but these patients were coded as heavy drinkers). Our referent category will be current moderate drinkers.
Competing-risk Cox proportional hazard models will be used to examine the association between drinking category and different cardiovascular disease phenotypes. Competing-risk regression takes into account the instantaneous failure rates of specific competing-causes (i.e. different cardiovascular phenotypes and death from non-coronary causes) - not doing so may overestimate the association between drinking categories and outcome. A detailed analytic protocol is available upon request.
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), secondary care (HES) 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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patient in a GPRD registered practice that has consented to the linkage process (who also met data quality standards).
Exclusion Criteria
* Cause of death unknown.
30 Years
ALL
No
Sponsors
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University College, London
OTHER
Responsible Party
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Harry Hemingway
Professor of Clinical Epidemiology
Principal Investigators
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Steven Bell, PhD
Role: PRINCIPAL_INVESTIGATOR
University College, London
Harry Hemingway, FRCP
Role: STUDY_DIRECTOR
University College, London
Locations
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University College London
London, , United Kingdom
Countries
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References
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Ronksley PE, Brien SE, Turner BJ, Mukamal KJ, Ghali WA. Association of alcohol consumption with selected cardiovascular disease outcomes: a systematic review and meta-analysis. BMJ. 2011 Feb 22;342:d671. doi: 10.1136/bmj.d671.
Roerecke M, Rehm J. The cardioprotective association of average alcohol consumption and ischaemic heart disease: a systematic review and meta-analysis. Addiction. 2012 Jul;107(7):1246-60. doi: 10.1111/j.1360-0443.2012.03780.x. Epub 2012 Mar 21.
Mukamal K. Alcohol intake and noncoronary cardiovascular diseases. Ann Epidemiol. 2007 May;17(5 Suppl):S8-S12. doi: 10.1016/j.annepidem.2007.01.003.
Stockwell T, Greer A, Fillmore K, Chikritzhs T, Zeisser C. How good is the science? BMJ. 2012 Mar 27;344:e2276; author reply e2294. doi: 10.1136/bmj.e2276. No abstract available.
Denaxas SC, George J, Herrett E, Shah AD, Kalra D, Hingorani AD, Kivimaki M, Timmis AD, Smeeth L, Hemingway H. Data resource profile: cardiovascular disease research using linked bespoke studies and electronic health records (CALIBER). Int J Epidemiol. 2012 Dec;41(6):1625-38. doi: 10.1093/ije/dys188. Epub 2012 Dec 5.
Bell S, Daskalopoulou M, Rapsomaniki E, George J, Britton A, Bobak M, Casas JP, Dale CE, Denaxas S, Shah AD, Hemingway H. Association between clinically recorded alcohol consumption and initial presentation of 12 cardiovascular diseases: population based cohort study using linked health records. BMJ. 2017 Mar 22;356:j909. doi: 10.1136/bmj.j909.
Related Links
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CALIBER project website
UCL Research Department of Epidemiology and Public Health
Other Identifiers
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086091/Z/08/Z
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
RP-PG-0407-10314
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CALIBER 12-02
Identifier Type: -
Identifier Source: org_study_id
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