Premature Coronary Artery Disease in Women - Risk Factors and Prognosis - Full Text View

Sponsored by:	Institute of Cardiology, Warsaw, Poland
Information provided by:	Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:	NCT00544739

Purpose

Cardiovascular risk in women is systematically underestimated by both - society and physicians. Women younger than 50 years of age with acute coronary syndrome have 2x higher mortality compared with age-matched men. A number of common vascular-disease-related conditions are more frequent in women than in men. Women develop a more severe or different form of vascular disease then men. Variability of onset, relative risk, and the synergy of traditional and novel risk factors creates a challenge to physicians possibly resulting in suboptimal management and disregard in women presenting with angina symptoms.

During last 10 years the rise in coronary artery disease (CAD) prevalence in younger women is observed. Emerging data suggest a unique risk profile in women (hypoestrogenemia with adverse effects of a protracted dysmetabolic state). The risk factors assessment and the risk factors profiles in women that are associated with CAD may be different than in men and thus merit reassessment.

Purpose The primary objective of this study is to determine characteristics and prognosis of women with premature coronary artery disease and to evaluate the extent of atherosclerosis

Condition
Coronary Atherosclerosis

MedlinePlus related topics: Coronary Artery Disease Vascular Diseases

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Premature Coronary Artery Disease in Women - Risk Factors and Prognosis

Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:

Comparison of clinical characteristics between study group and matched controls [ Time Frame: 1-year (short-term), 4-year (long-term) ] [ Designated as safety issue: No ]
Association of clinical factors to extent and advance of atherosclerosis [ Time Frame: 1-year (short-term), 4-year (long-term) ] [ Designated as safety issue: No ]
Predictive role of clinical factors on prognosis in terms of MACE [ Time Frame: 1-year (short-term), 4-year (long-term) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Predictive role of clinical factors on prognosis in terms of Vascular Events [ Time Frame: 1-year, 2-year, 3-year, 4-year ] [ Designated as safety issue: No ]
Predictive role of clinical factors on prognosis in terms of components of Vascular Events and total mortality [ Time Frame: 1-year, 2-year, 3-year, 4-year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

whole blood, serum

Enrollment:	670
Study Start Date:	April 2005
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 323 women with established coronary artery disease before 55 year of age
2 347 clinically healthy, age matched women selected from the National Health Survey WOBASZ study with negative history of CVD or negative exertional chest pain.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Cases: Consecutive women with onset of evident CAD before 55 years of age (admitted to coronary angiography because of acute coronary syndrome, stable angina or revascularization procedure Controls: age-matched healthy women selected from participants examined between 2004-2006 in the National Health Survey - WOBASZ study with negative history of exertional chest pain, angina, hospitalization of revascularization procedures or coronary treatment

Criteria

Inclusion Criteria:

Patients: Consecutive women with onset of evident CAD before 55 years of age (admitted to coronary angiography because of acute coronary syndrome, stable angina or revascularization procedure)
agreement to participate the study
Controls : age-matched healthy women selected from participants examined between 2004-2006 in the National Health Survey - WOBASZ study with negative history of exertional chest pain, angina, hospitalization of revascularization procedures or coronary treatment.

Exclusion Criteria:

inability to give informed consent death before discharge during the index hospitalization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544739

Locations

Poland
Institute of Cardiology,
Warsaw, Poland, 04-628

Sponsors and Collaborators

Institute of Cardiology, Warsaw, Poland

Investigators

Principal Investigator:

Barbara M Lubiszewska

Institute of Cardiology, Warsaw, Poland

More Information

Responsible Party:	Institute of Cardiology, Warsaw, Poland ( Vice-Director for Research Affairs, Assoc. Prof. Zofia T. Bilinska )
Study ID Numbers:	2 P05B 013 28
Study First Received:	October 15, 2007
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00544739
Health Authority:	Poland: Ministry of Scientific Research and Information Technology

Keywords provided by Institute of Cardiology, Warsaw, Poland:

Coronary Artery Disease
Premature
Female

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Atherosclerosis
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Ischemia
Arteriosclerosis
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009