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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01164371
• Other study ID #: CALIBER-09-05
• Status: Completed
• Phase: N/A
• First received: July 15, 2010
• Last updated: May 11, 2016
• Start date: July 2010
• Est. completion date: November 2013

Study information

• Verified date: May 2016
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1758584
• Est. completion date: November 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 100 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Infarction

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	Barts and the London School of Medicine and Dentistry, London School of Hygiene and Tropical Medicine

References & Publications (10)

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. doi: 10.1136/bmj.b3058. — View Citation

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. doi: 10.1136/hrt.2008.155804. Epub 2009 Jan 15. — View Citation

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. — View Citation

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. doi: 10.1161/CIRCULATIONAHA.107.720953. Epub 2008 Mar 17. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1001/archinternmed.2009.332. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	stable angina	diagnosis of angina following symptom free state	up to 15 years from entry into cohort	No
Secondary	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	No

External Links

•   CArdiovascular disease research Linking Bespoke studies and Electronic Records