Gender Differences in the Development, Treatment and Prognosis of Coronary Disease: A CALIBER Study
Condition: Coronary Disease; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Myocardial Infarction; Coronary Disease; Coronary Artery Disease
Study type: Observational

Summary: 
      The initial manifestation of symptomatic coronary disease can range from angina (or symptoms
      of angina), unheralded acute coronary syndrome (ACS), or unheralded coronary death. A better
      understanding of gender differences in initial presentation of coronary disease and the rate
      and predictors of progression to subsequent stages in coronary disease could help to identify
      which gender- specific factors might reduce or slow transition to more serious disease states
      and improve outcomes. The investigators' research focuses on the role primary care management
      of cardiovascular risk factors plays in gender differences in the progression to subsequent
      disease states and to mortality.
    

Detailed description: 
      The initial manifestation of symptomatic coronary disease can range from angina (or symptoms
      of angina), unheralded acute coronary syndrome, or unheralded coronary death. Gender
      differences in initial presentation of coronary disease and the rate and predictors of
      progression to subsequent stages in coronary disease are not well understood. Furthermore,
      while the management of coronary risk factors in primary care is hypothesized to play a key
      role in the rate and timing of such transitions, little is known about the impact such
      management has on gender differences these transitions and outcomes.

      Study Objectives:

        1. To determine gender differences in probabilities of transitions from symptom-free state
           to mortality for each of three patient coronary disease pathways, where the initial
           disease manifestation is angina, myocardial infarction or unheralded coronary death.

        2. To determine the role management of coronary risk factors in primary care has in
           explaining any gender differences in transitions from symptom-free state to mortality
           for each of the three patient coronary disease pathways.

      A statistical analytic protocol for the first part of this study, comparing patients with
      unheralded coronary death to patients free of symptomatic coronary disease, dated June 2010,
      is available on request. A second statistical analytic protocol for the second part of this
      study, comparing initial presentation of coronary disease, within a framework of competing
      risks of atherosclerotic disease, dated December 2011, is available on 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) 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).
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will include all adults aged 35 or over in General Practice Research
        Database (GPRD), registered with an up-to-standard practice with at least 1 year of
        continuous follow-up.

        Further details on defining up-to-standard practices within GPRD are available from
        http://www.gprd.com/home/
      
Keywords: coronary disease; cardiovascular disease; cardiovascular risk; cardiovascular risk management; primary care; angina; stable angina; angina pectoris; acute coronary syndrome; coronary death; unheralded acute coronary syndrome; unheralded coronary death; gender differences; sex differences; myocardial infarction; ST elevation myocardial infarction; non ST elevation myocardial infarction; STEMI; nSTEMI; unstable angina