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Premature Coronary Artery Disease in Women - Risk Factors and Prognosis (PRECADIW)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT00544739
First received: October 15, 2007
Last updated: January 16, 2012
Last verified: January 2012
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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

whole blood, serum


Enrollment: 670
Study Start Date: April 2005
Study Completion Date: September 2010
Primary Completion Date: June 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

Publications:

Responsible Party: Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT00544739     History of Changes
Other Study ID Numbers: 2 P05B 013 28
Study First Received: October 15, 2007
Last Updated: January 16, 2012
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Institute of Cardiology, Warsaw, Poland:
Coronary Artery Disease
Premature
Female

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 17, 2012