Cardiovascular Diseases Clinical Trial
To determine if selected circulating blood factors that reflect enhanced thrombogenesis are associated with an increased incidence of recurrent coronary events, including cardiac death or non-fatal myocardial infarction.
DESIGN NARRATIVE:
In this multicenter, collaborative, prospective study, patients hospitalized with a
myocardial infarction were enrolled from ten geographically dispersed centers. Five
thrombogenic- related blood factors were quantitated, and formed the centerpiece of this
study: 1) lipoprotein(a) [Lp(a)] - a quantitative genetic factor that contains
apolipoprotein B, has a structural homology to plasminogen, interferes with intrinsic
thrombolytic activity, and represents a crossover link in the thrombogenesis/atherogenesis
hypothesis; 2) soluble fibrin - a system indicator of coagulation activity in the ongoing
conversion of fibrinogen to insoluble fibrin strands; 3) plasminogen activator inhibitor-1
(PAI-1) - an important regulator of the fibrinolytic system, it interferes with intrinsic
t-PA activity; 4) coagulation Factor VII -high levels lead to increased thrombogenesis and
have been associated with an increased risk of ischemic heart disease; and- 5) von
Willebrand factor - it binds to platelet glycoproteins, contributes to local thrombus
formation, and it is elevated in patients at increased risk of coronary thrombosis.
The primary analysis utilized a time-dependent survivors hip model (Cox regression) to
determine the presence or absence of an association between one or more of these factors and
subsequent thrombotic-related coronary events. Secondary objectives included: 1) to
determine if there was a statistical association between the thrombogenic factors and
conventional hematologic/lipid parameters, and to evaluate their interactions regarding
coronary events; and 2) to determine if thrombogenic factors had uniform effects on coronary
event rates across various subgroups.
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