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

This study has been completed.
Sponsor:
Collaborators:
Barts and the London School of Medicine and Dentistry
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Julie George, University College, London
ClinicalTrials.gov Identifier:
NCT01164371
First received: July 15, 2010
Last updated: January 8, 2014
Last verified: January 2014

July 15, 2010
January 8, 2014
July 2010
September 2012   (final data collection date for primary outcome measure)
coronary mortality (ICD 10 I20-I25) [ Time Frame: up to 15 years from entry into cohort ] [ Designated as safety issue: No ]
coronary mortality, following symptom free state, diagnosed angina or acute coronary syndrome
Same as current
Complete list of historical versions of study NCT01164371 on ClinicalTrials.gov Archive Site
  • stable angina [ Time Frame: up to 15 years from entry into cohort ] [ Designated as safety issue: No ]
    diagnosis of angina following symptom free state
  • acute non-fatal acute coronary syndrome, comprising ST elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina [ Time Frame: up to 15 years from entry into cohort ] [ Designated as safety issue: No ]
    acute coronary syndrome following either symptom-free state (unheralded) or stable angina
Same as current
Not Provided
Not Provided
 
Gender Differences in the Development, Treatment and Prognosis of Coronary Disease: A CALIBER Study
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

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.

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
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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/

  • Coronary Disease
  • Cardiovascular Disease
Not Provided
  • Initial presentation of coronary disease - Stable angina
    Patients whose initial symptomatic presentation of coronary disease is stable angina (either diagnosis or symptoms)
  • Initial presentation of coronary disease - ACS
    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
    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
    Patients without symptomatic presentation of coronary disease, either alive or dead from non-coronary cause

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1758584
November 2013
September 2012   (final data collection date for primary outcome measure)

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
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01164371
CALIBER-09-05
Yes
Julie George, University College, London
University College, London
  • Barts and the London School of Medicine and Dentistry
  • London School of Hygiene and Tropical Medicine
Principal Investigator: Julie George, MSc University College, London
University College, London
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP