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

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:

MedlinePlus related topics: Angina Coronary Artery Disease Heart Attack

U.S. FDA Resources

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

Estimated Enrollment:	800000
Study Start Date:	July 2010
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2013 (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:

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).

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

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:

CArdiovascular disease research Linking Bespoke studies and Electronic Records This link exits the ClinicalTrials.gov site

Publications:

Richards H, McConnachie A, Morrison C, Murray K, Watt G. Social and gender variation in the prevalence, presentation and general practitioner provisional diagnosis of chest pain. J Epidemiol Community Health. 2000 Sep;54(9):714-8.

Hemingway H, Langenberg C, Damant J, Frost C, Pyörälä K, Barrett-Connor E. Prevalence of angina in women versus men: a systematic review and meta-analysis of international variations across 31 countries. Circulation. 2008 Mar 25;117(12):1526-36. Epub 2008 Mar 17. Review.

Hemingway H, McCallum A, Shipley M, Manderbacka K, Martikainen P, Keskimäki I. Incidence and prognostic implications of stable angina pectoris among women and men. JAMA. 2006 Mar 22;295(12):1404-11. Erratum in: JAMA. 2006 Jun 7;295(21):2482.

Buckley BS, Simpson CR, McLernon DJ, Murphy AW, Hannaford PC. Five year prognosis in patients with angina identified in primary care: incident cohort study. BMJ. 2009 Aug 6;339:b3058.

Daly C, Clemens F, Lopez Sendon JL, Tavazzi L, Boersma E, Danchin N, Delahaye F, Gitt A, Julian D, Mulcahy D, Ruzyllo W, Thygesen K, Verheugt F, Fox KM; Euro Heart Survey Investigators. Gender differences in the management and clinical outcome of stable angina. Circulation. 2006 Jan 31;113(4):490-8.

Murabito JM, Evans JC, Larson MG, Levy D. Prognosis after the onset of coronary heart disease. An investigation of differences in outcome between the sexes according to initial coronary disease presentation. Circulation. 1993 Dec;88(6):2548-55.

Yawn BP, Wollan PC, Jacobsen SJ, Fryer GE, Roger VL. Identification of women's coronary heart disease and risk factors prior to first myocardial infarction. J Womens Health (Larchmt). 2004 Dec;13(10):1087-100.

Champney KP, Frederick PD, Bueno H, Parashar S, Foody J, Merz CN, Canto JG, Lichtman JH, Vaccarino V; NRMI Investigators. The joint contribution of sex, age and type of myocardial infarction on hospital mortality following acute myocardial infarction. Heart. 2009 Jun;95(11):895-9. Epub 2009 Jan 15.

Vaccarino V, Parsons L, Peterson ED, Rogers WJ, Kiefe CI, Canto J. Sex differences in mortality after acute myocardial infarction: changes from 1994 to 2006. Arch Intern Med. 2009 Oct 26;169(19):1767-74.

MacIntyre K, Stewart S, Capewell S, Chalmers JW, Pell JP, Boyd J, Finlayson A, Redpath A, Gilmour H, McMurray JJ. Gender and survival: a population-based study of 201,114 men and women following a first acute myocardial infarction. J Am Coll Cardiol. 2001 Sep;38(3):729-35.

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:	December 19, 2011
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:

Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Infarction
Myocardial Ischemia

Heart Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 23, 2013