NCT01164371|CompletedDMC
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Sponsor study identifier
observational
1,758,584
0 countries
N/A
Study Start
July 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2012
Actual (reported)Study Completion
November 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2010
Date type not reportedThis date has not been verified as actual or estimated.
July 15, 2010
Actual (reported)July 16, 2010
Actual (reported)September 2012
Actual (reported)November 2013
Actual (reported)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
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
Patients whose initial symptomatic presentation of coronary disease is stable angina (either diagnosis or symptoms)
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
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
Patients without symptomatic presentation of coronary disease, either alive or dead from non-coronary cause
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/
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.
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.
Julie George, MSc
University College, London
1,758,584 participants (actual enrollment reported by the registry).
First Submitted
July 15, 2010
First Posted
July 16, 2010
Study Start
July 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Primary Completion
September 2012
Actual (reported)Study Completion
November 2013
Actual (reported)Last Updated
May 12, 2016
Record last verified: 2016-05
Permissions to used anonymised linked data from data owners prohibit further sharing of the data
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