Premature Coronary Artery Disease in Women - Risk Factors and Prognosis (PRECADIW)
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|ClinicalTrials.gov Identifier: NCT00544739|
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : January 18, 2012
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 or disease|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||670 participants|
|Observational Model:||Case Control|
|Official Title:||Premature Coronary Artery Disease in Women - Risk Factors and Prognosis|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||September 2010|
323 women with established coronary artery disease before 55 year of age
347 clinically healthy, age matched women selected from the National Health Survey WOBASZ study with negative history of CVD or negative exertional chest pain.
- Comparison of clinical characteristics between study group and matched controls [ Time Frame: 1-year (short-term), 4-year (long-term) ]
- Association of clinical factors to extent and advance of atherosclerosis [ Time Frame: 1-year (short-term), 4-year (long-term) ]
- Predictive role of clinical factors on prognosis in terms of MACE [ Time Frame: 1-year (short-term), 4-year (long-term) ]
- Predictive role of clinical factors on prognosis in terms of Vascular Events [ Time Frame: 1-year, 2-year, 3-year, 4-year ]
- 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 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544739
|Institute of Cardiology,|
|Warsaw, Poland, 04-628|
|Principal Investigator:||Barbara M Lubiszewska||Institute of Cardiology, Warsaw, Poland|