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
  Purpose

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.


Condition
Coronary Disease
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 1758584
Study Start Date: July 2010
Study Completion Date: November 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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).

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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/

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164371

Sponsors and Collaborators
University College, London
Barts and the London School of Medicine and Dentistry
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Julie George, MSc University College, London
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Julie George, NIHR Doctoral Fellow, University College, London
ClinicalTrials.gov Identifier: NCT01164371     History of Changes
Other Study ID Numbers: CALIBER-09-05
Study First Received: July 15, 2010
Last Updated: January 8, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University College, London:
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

Additional relevant MeSH terms:
Myocardial Infarction
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on October 19, 2014