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

University College London (UCL) logo

University College London (UCL)

Status

Completed

Conditions

Coronary Disease
Cardiovascular Disease

Study type

Observational

Funder types

Other

Identifiers

NCT01164371
CALIBER-09-05

Details and patient eligibility

About

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.

Full 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).

Enrollment

1,758,584 patients

Sex

All

Ages

35 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

1,758,584 participants in 4 patient groups

Initial presentation of coronary disease - Stable angina
Description:
Patients whose initial symptomatic presentation of coronary disease is stable angina (either diagnosis or symptoms)
Initial presentation of coronary disease - ACS
Description:
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
Description:
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
Description:
Patients without symptomatic presentation of coronary disease, either alive or dead from non-coronary cause

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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