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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00544739
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : January 18, 2012
Sponsor:
Information provided by (Responsible Party):
Institute of Cardiology, Warsaw, Poland

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


Condition or disease
Coronary Atherosclerosis

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 670 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Premature Coronary Artery Disease in Women - Risk Factors and Prognosis
Study Start Date : April 2005
Primary Completion Date : June 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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.



Primary Outcome Measures :
  1. Comparison of clinical characteristics between study group and matched controls [ Time Frame: 1-year (short-term), 4-year (long-term) ]
  2. Association of clinical factors to extent and advance of atherosclerosis [ Time Frame: 1-year (short-term), 4-year (long-term) ]
  3. Predictive role of clinical factors on prognosis in terms of MACE [ Time Frame: 1-year (short-term), 4-year (long-term) ]

Secondary Outcome Measures :
  1. Predictive role of clinical factors on prognosis in terms of Vascular Events [ Time Frame: 1-year, 2-year, 3-year, 4-year ]
  2. 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
whole blood, serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

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


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

Publications:
Responsible Party: Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT00544739     History of Changes
Other Study ID Numbers: 2 P05B 013 28
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Premature Birth
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications