Cardiovascular Diseases Clinical Trial
To determine inflammation markers over time in cardiovascular disease. To test the hypothesis that measures of coagulation and fibrinolysis correlate with the incidence of coronary heart disease (CHD) and other thrombosis related disorders, and to help identify those individuals at greatest risk, using the Cardiovascular Health Study (CHS) and Honolulu Heart Program (HHP) populations. These two genetically distinct populations had different event rates for CHD, and offered a unique opportunity to test associations that were uncovered by comparing results across populations.
BACKGROUND:
Coronary heart disease (CHD) and other thrombosis related disorders are a major source of
morbidity and mortality in the United States and the world. To a certain extent they are
diseases of the elderly, with the majority of overt CHD occurring in persons over the age of
65. Recently, fibrinogen and factor VII have been implicated as independent CHD risk factors
in middle age populations, although causative roles have not been established. These studies
increased understanding of the relationship of thrombosis to cardiovascular risk.
DESIGN NARRATIVE:
Beginning in 1992, the study tested the hypothesis that measures of coagulation and
fibrinolysis correlated with the incidence of coronary heart disease (CHD) and other
thrombosis related disorders, and identified those individuals at greatest risk, using the
Cardiovascular Health Study (CHS) and Honolulu Heart Program (HHP) populations. These two
genetically distinct populations had different event rates for CHD, and offered a unique
opportunity to test associations that were uncovered by comparing results across
populations. The study examined selected measures of coagulation and fibrinolysis in
individuals 65 years and older: measures of pro-coagulation (factor antigen VII, prothrombin
fragment 1.2, fibrinopeptide A and thrombin - antithrombin III complex), measures of
coagulation inhibition (protein C and protein S, antithrombin III, and the lipoprotein
associated coagulation inhibitor (LACI), and measures of fibrinolysis (plasminogen activator
inhibitor-1 (PAI-1), tissue plasminogen activator-PAI-1 complex, plasmin-alpha-2 antiplasmin
complex, and Lp(a).
A case/control design was used to determine the relationship between the above measurements
and the incidence of CHD (and other thrombosis related disorders). The short and medium term
biological variability of the above measures was determined to aid in interpretation of
observed differences. Finally, the distribution of the above measurements was established in
both cohorts and their relationships to other variables in the extensive CHS and HHP data
bases ascertained.
The study was renewed in 1999 to determine inflammation markers over time in cardiovascular
disease.
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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