Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT00005358
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT00005358
Study Brief:
Protocol Section:
NCT00005358