Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006539
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-11-28
Brief Title:
Thrombotic Inflammatory Gene Markers of CVD in Women
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-03
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:
None
Brief Summary:
To evaluate a series of thrombotic inflammatory and genetic markers for myocardial infarction among participants in the Womens Health Initiative Observational Study WHI-OS
Detailed Description:
BACKGROUND
Over the past 50 years considerable progress has been made in understanding factors that stimulate the development of atherosclerosis and other manifestations of preclinical cardiovascular disease and in documenting the 2- to 4-fold higher risk of subsequent myocardial infarction or other morbid events in asymptomatic individuals with such pathological transformations in arteries or the heart However much less information is available about the factors triggers that precipitate morbid and mortal events in high-risk individuals Recent work by Paul Ridker and colleagues and other groups has identified associations between the presence of markers of prothrombotic tendencies inflammation and immune activation and myocardial infarction and other cardiovascular disease CVD events However most available data have been obtained in men and less is known about the relevance of these newer risk factors and potential triggers to stimulation of atherosclerosis and precipitation of CVD events in women In this context research to examine the relation of both relatively new and potentially novel triggers to subsequent myocardial infarction in women is of considerable potential clinical and biological significance
DESIGN NARRATIVE
Drs Ridker and colleagues comprehensively evaluated a series of thrombotic inflammatory and genetic markers for myocardial infarction MI among participants in the Womens Health Initiative Observational Study WHI-OS a prospective cohort study of over 90000 ethnically representative post-menopausal American women aged 50-79 years Employing a prospective nested case-control design they assayed baseline plasma and buffy coat samples for nine markers of increased thrombotic potential tissue-type plasminogen activator tPA plasminogen activator inhibitor type 1 PAI-1 total plasma homocysteine prothrombin fragment F12 D-dimer APC-R C-reactive protein interleukin-6 and sICAM-1 to determine whether elevations of these parameters led to future MI or coronary death They also explored common genetic polymorphisms in the tPA PAI-1 MTHFR thrombomodulin prothrombin and factor V genes so that both inherited and environmental determinants of coronary thrombosis in women could simultaneously be evaluated Case subjects were WHI-OS participants who were free of cardiovascular disease at study entry and subsequently developed a documented MI or coronary death during follow-up N 650 Control subjects were selected from study participants who remained free of disease during follow-up controls were 11 matched to cases by age smoking status ethnicity and follow-up time Data on usual risk factors hormone replacement therapy and standard lipid profiles were used to evaluate for potential confounding and effect modification The analyses took advantage of a unique and unprecedented blood bank from a well-characterized ethnically diverse large-scale cohort of post-menopausal women with ongoing follow-up and high quality endpoint verification thereby providing an efficient way to critically evaluate the hypothesized roles of hemostasis thrombosis and inflammation as risk factors for future MI and coronary death among American women
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Over the past 50 years considerable progress has been made in understanding factors that stimulate the development of atherosclerosis and other manifestations of preclinical cardiovascular disease and in documenting the 2- to 4-fold higher risk of subsequent myocardial infarction or other morbid events in asymptomatic individuals with such pathological transformations in arteries or the heart However much less information is available about the factors triggers that precipitate morbid and mortal events in high-risk individuals Recent work by Paul Ridker and colleagues and other groups has identified associations between the presence of markers of prothrombotic tendencies inflammation and immune activation and myocardial infarction and other cardiovascular disease CVD events However most available data have been obtained in men and less is known about the relevance of these newer risk factors and potential triggers to stimulation of atherosclerosis and precipitation of CVD events in women In this context research to examine the relation of both relatively new and potentially novel triggers to subsequent myocardial infarction in women is of considerable potential clinical and biological significance
DESIGN NARRATIVE
Drs Ridker and colleagues comprehensively evaluated a series of thrombotic inflammatory and genetic markers for myocardial infarction MI among participants in the Womens Health Initiative Observational Study WHI-OS a prospective cohort study of over 90000 ethnically representative post-menopausal American women aged 50-79 years Employing a prospective nested case-control design they assayed baseline plasma and buffy coat samples for nine markers of increased thrombotic potential tissue-type plasminogen activator tPA plasminogen activator inhibitor type 1 PAI-1 total plasma homocysteine prothrombin fragment F12 D-dimer APC-R C-reactive protein interleukin-6 and sICAM-1 to determine whether elevations of these parameters led to future MI or coronary death They also explored common genetic polymorphisms in the tPA PAI-1 MTHFR thrombomodulin prothrombin and factor V genes so that both inherited and environmental determinants of coronary thrombosis in women could simultaneously be evaluated Case subjects were WHI-OS participants who were free of cardiovascular disease at study entry and subsequently developed a documented MI or coronary death during follow-up N 650 Control subjects were selected from study participants who remained free of disease during follow-up controls were 11 matched to cases by age smoking status ethnicity and follow-up time Data on usual risk factors hormone replacement therapy and standard lipid profiles were used to evaluate for potential confounding and effect modification The analyses took advantage of a unique and unprecedented blood bank from a well-characterized ethnically diverse large-scale cohort of post-menopausal women with ongoing follow-up and high quality endpoint verification thereby providing an efficient way to critically evaluate the hypothesized roles of hemostasis thrombosis and inflammation as risk factors for future MI and coronary death among American women
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL063293 | NIH | None | httpsreporternihgovquickSearchR01HL063293 |