Gender Differences in the Development, Treatment and Prognosis of Coronary Disease: A CALIBER Study

Study Overview
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Brief Summary
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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
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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: 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. 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).

Official Title
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Gender Differences in the Development and Prognosis of Coronary Disease Where Initial Disease Manifestation is Stable Angina, Myocardial Infarction or Unheralded Coronary Death: A CALIBER Study Using Linked GPRD-MINAP Data

Conditions
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Coronary Disease, Cardiovascular Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: as above Exclusion Criteria: patients with a history of ischaemic heart disease, heart failure, cerebrovascular disease, peripheral arterial disease or congenital coronary anomalies, prior to entry into the cohort patients with symptoms of chest pain in the 6 months prior to cohort entry patients < 35 or >100 years of age after eligibility for entry to the cohort

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Initial presentation of coronary disease - Stable angina<br>Patients whose initial symptomatic presentation of coronary disease is stable angina (either diagnosis or symptoms) | |
| Initial presentation of coronary disease - ACS<br>Patients whose initial symptomatic presentation of coronary disease is acute coronary syndrome (ST-elevation myocardial infarction [STEMI], non-STEMI [nSTEMI] or unstable angina) without prior stable angina or symptoms of stable angina | |
| Initial presentation of coronary disease - Coronary death<br>Patients whose initial symptomatic manifestation of coronary disease is coronary death with no prior diagnosis of stable angina (or symptoms of stable angina) or diagnosis of acute coronary syndrome | |
| Initial presentation of coronary disease - None<br>Patients without symptomatic presentation of coronary disease, either alive or dead from non-coronary cause | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coronary mortality (ICD 10 I20-I25) | coronary mortality, following symptom free state, diagnosed angina or acute coronary syndrome | up to 15 years from entry into cohort | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stable angina | diagnosis of angina following symptom free state | up to 15 years from entry into cohort | 
| acute non-fatal acute coronary syndrome, comprising ST elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina | acute coronary syndrome following either symptom-free state (unheralded) or stable angina | up to 15 years from entry into cohort | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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