Cardiovascular Diseases Clinical Trial
To evaluate a series of thrombotic, inflammatory, and genetic markers for myocardial infarction among participants in the Women's Health Initiative Observational Study (WHI-OS).
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 Women's Health
Initiative Observational Study (WHI-OS), a prospective cohort study of over 90,000
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 F1+2, 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 1:1 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.
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