Ignite Creation Date:
2024-05-05 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00544739
Status:
COMPLETED
Last Update Posted:
2012-01-18
First Post:
2007-10-15
Brief Title:
Premature Coronary Artery Disease in Women - Risk Factors and Prognosis
Sponsor:
National Institute of Cardiology Warsaw Poland
Organization:
National Institute of Cardiology Warsaw Poland
Study Overview
Official Title:
Premature Coronary Artery Disease in Women - Risk Factors and Prognosis
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRECADIW
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
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
Detailed Description:
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 200563suplIV 605613
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
The study protocol is approved by the Institutional Review Boards and Local Bioethics Committee
Follow-up All patients are contacted at 6 months after discharge from the hospital and then every 6 months for at least 4 years to assess symptom status menstrual status and occurrence of cardiovascular events MACE including death nonfatal myocardial infarction coronary revascularization cardiac surgery and hospitalization for unstable angina
Study Endpoints
Primary Outcome Measures
1 To evaluate the prevalence of atherosclerosis risk factors in women with premature CAD including family history social environmental clinical traditional and novel risk factors menopausal status and its association with early onset of the disease as compared to matched controls
2 To evaluate the association of clinical factors to extent and advance of atherosclerosis
3 To evaluate predictive role of clinical factors and in particular impaired fasting glucose abdominal obesity hypertension metabolic syndrome inflammatory markers coexisting inflammatory and immunologic diseases on prognosis at 1 year and long-term follow-up in terms of MACE cardiovascular death nonfatal MI revascularization hospitalization due to heart failure IIIIV or acute coronary syndrome
Secondary Outcome Measures
1 To evaluate predictive role of clinical factors and in particular impaired fasting glucose abdominal obesity hypertension metabolic syndrome inflammatory markers coexisting inflammatory and immunologic diseases on prognosis in terms of Vascular Events MACE hospitalization due to CAD progression major arrhythmia with ICD implantation and stroke
2 To evaluate predictive role of clinical factors and in particular impaired fasting glucose abdominal obesity hypertension metabolic syndrome inflammatory markers coexisting inflammatory and immunologic diseases on prognosis in terms of components of Vascular Events and total mortality
Endpoints assessment
Independent endpoint classification committee comprising of 2 not involved into study procedures cardiologists will review documentation of the event and classify it
The study may have significant implications for improvement identification and management of female patients at risk of premature atherosclerosis providing more gender-specific data for efficacy and safety of cardiovascular medication Better scientific recognition will result in better awareness of risk and effective prevention of coronary artery disease in young females in optimizing the delivery of heart care to population of young women and rationale for guidelines specific for women
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
The study protocol is approved by the Institutional Review Boards and Local Bioethics Committee
Follow-up All patients are contacted at 6 months after discharge from the hospital and then every 6 months for at least 4 years to assess symptom status menstrual status and occurrence of cardiovascular events MACE including death nonfatal myocardial infarction coronary revascularization cardiac surgery and hospitalization for unstable angina
Study Endpoints
Primary Outcome Measures
1 To evaluate the prevalence of atherosclerosis risk factors in women with premature CAD including family history social environmental clinical traditional and novel risk factors menopausal status and its association with early onset of the disease as compared to matched controls
2 To evaluate the association of clinical factors to extent and advance of atherosclerosis
3 To evaluate predictive role of clinical factors and in particular impaired fasting glucose abdominal obesity hypertension metabolic syndrome inflammatory markers coexisting inflammatory and immunologic diseases on prognosis at 1 year and long-term follow-up in terms of MACE cardiovascular death nonfatal MI revascularization hospitalization due to heart failure IIIIV or acute coronary syndrome
Secondary Outcome Measures
1 To evaluate predictive role of clinical factors and in particular impaired fasting glucose abdominal obesity hypertension metabolic syndrome inflammatory markers coexisting inflammatory and immunologic diseases on prognosis in terms of Vascular Events MACE hospitalization due to CAD progression major arrhythmia with ICD implantation and stroke
2 To evaluate predictive role of clinical factors and in particular impaired fasting glucose abdominal obesity hypertension metabolic syndrome inflammatory markers coexisting inflammatory and immunologic diseases on prognosis in terms of components of Vascular Events and total mortality
Endpoints assessment
Independent endpoint classification committee comprising of 2 not involved into study procedures cardiologists will review documentation of the event and classify it
The study may have significant implications for improvement identification and management of female patients at risk of premature atherosclerosis providing more gender-specific data for efficacy and safety of cardiovascular medication Better scientific recognition will result in better awareness of risk and effective prevention of coronary artery disease in young females in optimizing the delivery of heart care to population of young women and rationale for guidelines specific for women
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None