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

NCT ID: NCT01164371

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1758584 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-11-30

Brief 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.

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).

Conditions

Coronary Disease; Cardiovascular Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Initial presentation of coronary disease - Stable angina

Patients whose initial symptomatic presentation of coronary disease is stable angina (either diagnosis or symptoms)

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Initial presentation of coronary disease - None

Patients without symptomatic presentation of coronary disease, either alive or dead from non-coronary cause

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barts and the London School of Medicine and Dentistry

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Julie George

NIHR Doctoral Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie George, MSc

Role: PRINCIPAL_INVESTIGATOR

University College, London

References

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Reference Type: BACKGROUND

PMID: 10942455 (View on PubMed)

Hemingway H, Langenberg C, Damant J, Frost C, Pyorala 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.

Reference Type: BACKGROUND

PMID: 18347213 (View on PubMed)

Hemingway H, McCallum A, Shipley M, Manderbacka K, Martikainen P, Keskimaki I. Incidence and prognostic implications of stable angina pectoris among women and men. JAMA. 2006 Mar 22;295(12):1404-11. doi: 10.1001/jama.295.12.1404.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 19661139 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 19858434 (View on PubMed)

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. doi: 10.1016/s0735-1097(01)01465-6.

Reference Type: BACKGROUND

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George J, Rapsomaniki E, Pujades-Rodriguez M, Shah AD, Denaxas S, Herrett E, Smeeth L, Timmis A, Hemingway H. How Does Cardiovascular Disease First Present in Women and Men? Incidence of 12 Cardiovascular Diseases in a Contemporary Cohort of 1,937,360 People. Circulation. 2015 Oct 6;132(14):1320-8. doi: 10.1161/CIRCULATIONAHA.114.013797. Epub 2015 Sep 1.

Reference Type: DERIVED

PMID: 26330414 (View on PubMed)

Rapsomaniki E, Timmis A, George J, Pujades-Rodriguez M, Shah AD, Denaxas S, White IR, Caulfield MJ, Deanfield JE, Smeeth L, Williams B, Hingorani A, Hemingway H. Blood pressure and incidence of twelve cardiovascular diseases: lifetime risks, healthy life-years lost, and age-specific associations in 1.25 million people. Lancet. 2014 May 31;383(9932):1899-911. doi: 10.1016/S0140-6736(14)60685-1.

Reference Type: DERIVED

PMID: 24881994 (View on PubMed)

Related Links

http://www.caliberresearch.org

CArdiovascular disease research Linking Bespoke studies and Electronic Records

Other Identifiers

CALIBER-09-05

Identifier Type: -

Identifier Source: org_study_id