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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01394549
Other study ID # 11320
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2011
Est. completion date March 2012

Study information

Verified date August 2019
Source French Cardiology Society
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Despite efforts of learned societies, community cardiology and more generally of most players in the health, cardiovascular diseases continue to be the leading cause of death among women in France and all over the Western world, there where they fell to second place among men. Clinical practice and the disparity between the sexes are still insufficiently known.

Multicenter observational study on a cross-week comparative basis with men


Description:

In France, as in other industrialized countries, ischemic heart disease is a major cause of morbidity and mortality in women. Work to improve epidemiological knowledge, prevention, screening, risk stratification and treatment of ischemic heart disease in women has a potential impact on all the issues listed.

There is therefore a double challenge:

- A public health issue to alert the female population on cardiovascular risk and its consequences, while the female population does not feel concerned by the potential danger.

- A challenge for health professionals so that they have the same thing vis-à-vis the cardiovascular prevention among women and whatever their field of practice.


Recruitment information / eligibility

Status Completed
Enrollment 319
Est. completion date March 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Women all patients and / or men regardless of age

- Admitted to a cardiology department (in the intensive care unit or cardiology traditional) week of the survey,

- Having presented an acute coronary syndrome, regardless of the type with or without ST segment above, with or without elevated troponin, complicated or not, regardless of its support invasive or conservative,

- Patients who agreed to participate in the study.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

References & Publications (9)

Alexander KP, Chen AY, Roe MT, Newby LK, Gibson CM, Allen-LaPointe NM, Pollack C, Gibler WB, Ohman EM, Peterson ED; CRUSADE Investigators. Excess dosing of antiplatelet and antithrombin agents in the treatment of non-ST-segment elevation acute coronary syndromes. JAMA. 2005 Dec 28;294(24):3108-16. Erratum in: JAMA. 2006 Feb 8;295(6):628. — View Citation

Bairey Merz CN, Shaw LJ, Reis SE, Bittner V, Kelsey SF, Olson M, Johnson BD, Pepine CJ, Mankad S, Sharaf BL, Rogers WJ, Pohost GM, Lerman A, Quyyumi AA, Sopko G; WISE Investigators. Insights from the NHLBI-Sponsored Women's Ischemia Syndrome Evaluation (WISE) Study: Part II: gender differences in presentation, diagnosis, and outcome with regard to gender-based pathophysiology of atherosclerosis and macrovascular and microvascular coronary disease. J Am Coll Cardiol. 2006 Feb 7;47(3 Suppl):S21-9. Review. — View Citation

Einstein AJ, Moser KW, Thompson RC, Cerqueira MD, Henzlova MJ. Radiation dose to patients from cardiac diagnostic imaging. Circulation. 2007 Sep 11;116(11):1290-305. Review. — View Citation

Kwok Y, Kim C, Grady D, Segal M, Redberg R. Meta-analysis of exercise testing to detect coronary artery disease in women. Am J Cardiol. 1999 Mar 1;83(5):660-6. — View Citation

Lerner DJ, Kannel WB. Patterns of coronary heart disease morbidity and mortality in the sexes: a 26-year follow-up of the Framingham population. Am Heart J. 1986 Feb;111(2):383-90. — View Citation

Michos ED, Nasir K, Braunstein JB, Rumberger JA, Budoff MJ, Post WS, Blumenthal RS. Framingham risk equation underestimates subclinical atherosclerosis risk in asymptomatic women. Atherosclerosis. 2006 Jan;184(1):201-6. — View Citation

Mieres JH, Shaw LJ, Arai A, Budoff MJ, Flamm SD, Hundley WG, Marwick TH, Mosca L, Patel AR, Quinones MA, Redberg RF, Taubert KA, Taylor AJ, Thomas GS, Wenger NK; Cardiac Imaging Committee, Council on Clinical Cardiology, and the Cardiovascular Imaging and Intervention Committee, Council on Cardiovascular Radiology and Intervention, American Heart Association. Role of noninvasive testing in the clinical evaluation of women with suspected coronary artery disease: Consensus statement from the Cardiac Imaging Committee, Council on Clinical Cardiology, and the Cardiovascular Imaging and Intervention Committee, Council on Cardiovascular Radiology and Intervention, American Heart Association. Circulation. 2005 Feb 8;111(5):682-96. Epub 2005 Feb 1. — View Citation

Stramba-Badiale M, Fox KM, Priori SG, Collins P, Daly C, Graham I, Jonsson B, Schenck-Gustafsson K, Tendera M. Cardiovascular diseases in women: a statement from the policy conference of the European Society of Cardiology. Eur Heart J. 2006 Apr;27(8):994-1005. Epub 2006 Mar 7. — View Citation

WRITING GROUP MEMBERS, Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-e215. doi: 10.1161/CIRCULATIONAHA.109.192667. Epub 2009 Dec 17. Erratum in: Circulation. 2010 Mar 30;121(12):e260. Stafford, Randall [corrected to Roger, Véronique L]. Circulation. 2011 Oct 18;124(16):e425. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical practices To assess clinical practices and disparities between men and women in the management of acute coronary syndrome 1 day