Premature Coronary Artery Disease in Women - Risk Factors and Prognosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 670
- 试验地点
- 1
- 主要终点
- Comparison of clinical characteristics between study group and matched controls
研究概览
简要总结
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
详细描述
• Study Design Single-center, standardized, case-control study designed to assess the prevalence and significance of novel and traditional risk factors of premature coronary artery disease in women. Phase I (April 30th 2005- January 1st 2008) enrolled women with onset of symptomatic coronary artery disease before 55 years of age. The control group of 347 clinically healthy, age matched women was selected from the National Health Survey WOBASZ study (Polish Multicenter Population Study designed by Epidemiology and Cardiovascular Disease Prevention and Health Promotion Department of Institute of Cardiology) according to specifically designed questionnaire for WOBASZ study, and only subjects with negative history of CVD or negative exertional chest pain were included (Rywik S, Kupść W, Piotrowski W, et al. Wieloośrodkowe ogólnopolskie badanie stanu zdrowia ludności - projekt WOBASZ Założenia metodyczne oraz logistyka. Kardiol Pol 2005;63(supl.IV) 605:613).
Definition of premature CAD in women contained onset of coronary artery disease (myocardial infarction or coronary revascularization) before 55 years of age. Study participants are enrolled after coronary angiography and after identification and screening the age of admitted patients for acute coronary syndrome, stable angina or revascularization procedure. At the time of enrollment, participants give written informed consent for the study.
Information on demographic factors, social characterization, life style, education, anthropometric measurements, symptom characteristics and anamnesis, gynecologic history, family history on CVD and cancer, physical examination data, personal or family history of CVD, socioeconomic status, cardiovascular assessments and medication used was obtained through the use of a structured case report form questionnaire (CRF).
Additional fasting blood samples (15ml) are drawn from every individual (patients and controls) and frozen immediately at -70 for genetic study and in patients only half blood samples are centrifuged, separated, and frozen immediately at -70o after processing.
Baseline evaluation consisted of CRF data, and collection of coronary angiography, carotid ultrasonography and laboratory data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •inability to give informed consent death before discharge during the index hospitalization
结局指标
主要结局
Comparison of clinical characteristics between study group and matched controls
时间窗: 1-year (short-term), 4-year (long-term)
Predictive role of clinical factors on prognosis in terms of MACE
时间窗: 1-year (short-term), 4-year (long-term)
Association of clinical factors to extent and advance of atherosclerosis
时间窗: 1-year (short-term), 4-year (long-term)
次要结局
- 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)