Premature Coronary Artery Disease in Women - Risk Factors and Prognosis

NCT00544739 | Completed

• 1 other identifier: 2 P05B 013 28
• Study Type: observational
• Target: 670
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Atherosclerosis

Keywords

Coronary Artery Disease; Premature; Female

Outcome Measures

Primary Outcomes (3)

• Comparison of clinical characteristics between study group and matched controls

  1-year (short-term), 4-year (long-term)

• Association of clinical factors to extent and advance of atherosclerosis

  1-year (short-term), 4-year (long-term)

• Predictive role of clinical factors on prognosis in terms of MACE

  1-year (short-term), 4-year (long-term)

Secondary Outcomes (2)

• Predictive role of clinical factors on prognosis in terms of Vascular Events

  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

  1-year, 2-year, 3-year, 4-year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead

Study Sites (1)

Institute of Cardiology,

Warsaw, 04-628, Poland

Location

Related Publications (2)

• Lubiszewska B, Kruk M, Broda G, Ksiezycka E, Piotrowski W, Kurjata P, Zielinski T, Ploski R. The impact of early menopause on risk of coronary artery disease (PREmature Coronary Artery Disease In Women--PRECADIW case-control study). Eur J Prev Cardiol. 2012 Feb;19(1):95-101. doi: 10.1177/1741826710394269. Epub 2011 Feb 21.

  PMID: 21450613 RESULT

• Lubiszewska B, Skora E, Kruk M, Broda G, Ksiezycka E, Kurjata P, Zielinski T, Ploski R. Prevalence of classical risk factors in Polish women with premature coronary artery disease. Kardiol Pol. 2010 Sep;68(9):1032-7.

  PMID: 20859896 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum

MeSH Terms

Conditions

Coronary Artery Disease; Premature Birth

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Barbara M Lubiszewska

  National Institute of Cardiology, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: October 16, 2007
• Study Start: April 1, 2005
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

PL (1)