The Role of Alcohol Consumption in the Aetiology of Different Cardiovascular Disease Phenotypes: a CALIBER Study

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Brief Title

The Role of Alcohol Consumption in the Aetiology of Different Cardiovascular Disease Phenotypes: a CALIBER Study

Official Title

The Role of Alcohol Consumption in the Aetiology of Different Cardiovascular Disease Phenotypes: a CALIBER Study Using Linked Electronic Health Records

Brief Summary

      The association between alcohol consumption and cardiovascular disease (CVD) has mostly been
      examined using broad endpoints or cause-specific mortality. The purpose of our study is to
      compare the effect of alcohol consumption in the aetiology of a range of cardiovascular
      disease phenotypes.

Detailed Description

      The relationship between cardiovascular diseases (CVDs) and alcohol consumption is complex.
      Moderate alcohol consumption has consistently been found to be associated with a reduced risk
      of commonly reported aggregates of CVD (e.g. coronary heart disease [CHD]) while heavy
      drinking (and abstaining from alcohol) is believed to be associated with an augmented risk.
      However, much remains to be clarified. For example, previous studies have typically been too
      small in size to adequately assess the impact of alcohol consumption on a range of major,
      pathologically distinct CVDs. Understanding the role of alcohol consumption in specific CVDs
      may provide novel insights into the mechanisms which give rise to the observed beneficial
      effects of moderate consumption for these aggregates.

      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).

Study Type

Observational

Primary Outcome

Initial presentation of cardiovascular disease

Secondary Outcome

 Non-CVD mortality

Condition

Chronic Stable Angina

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

Start Date

January 1997

Completion Date

December 2014

Primary Completion Date

December 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Aged ≥ 30 years.

          -  Patient in a GPRD registered practice that has consented to the linkage process (who
             also met data quality standards).

        Exclusion Criteria:

          -  A recorded history of any cardiovascular disease phenotype prior to entering the
             study.

          -  Cause of death unknown.

Gender

All

Ages

30 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Steven Bell, PhD, ,

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations

NCT ID

NCT01864031

Organization ID

CALIBER 12-02

Secondary IDs

086091/Z/08/Z

Responsible Party

Principal Investigator

Study Sponsor

University College, London

Study Sponsor

Steven Bell, PhD, Principal Investigator, University College, London

Verification Date

May 2013