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

NCT01164371 | Completed DMC

• 1 other identifier: CALIBER-09-05
• Study Type: observational
• Target: 1,758,584
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Disease; Cardiovascular Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• stable angina

  up to 15 years from entry into cohort

• acute non-fatal acute coronary syndrome, comprising ST elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina

  up to 15 years from entry into cohort

Study Arms (4)

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

Eligibility Criteria

• Age: 35 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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/

You may qualify if:

• as above

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• Barts and the London School of Medicine and Dentistry: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Related Publications (12)

• 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. doi: 10.1136/jech.54.9.714.

  PMID: 10942455 BACKGROUND

• 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.

  PMID: 18347213 BACKGROUND

• 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.

  PMID: 16551712 BACKGROUND

• 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.

  PMID: 19661139 BACKGROUND

• 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. doi: 10.1161/CIRCULATIONAHA.105.561647.

  PMID: 16449728 BACKGROUND

• 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. doi: 10.1161/01.cir.88.6.2548.

  PMID: 8252666 BACKGROUND

• 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. doi: 10.1089/jwh.2004.13.1087.

  PMID: 15650342 BACKGROUND

• 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.

  PMID: 19147625 BACKGROUND

• 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.

  PMID: 19858434 BACKGROUND

• 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.

  PMID: 11527625 BACKGROUND

• 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.

  PMID: 26330414 DERIVED

• 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.

  PMID: 24881994 DERIVED

Related Links

• CArdiovascular disease research Linking Bespoke studies and Electronic Records

MeSH Terms

Conditions

Coronary Disease; Cardiovascular Diseases; Angina Pectoris; Angina, Stable; Acute Coronary Syndrome; Myocardial Infarction; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Angina, Unstable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Julie George, MSc

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NIHR Doctoral Fellow

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 16, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2013
• Last Updated: May 12, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share