Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005358
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2000-05-25
Brief Title:
Thrombogenic Factors and Recurrent Coronary Events
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-01
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 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 lipoproteina Lpa - 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 thrombogenesisatherogenesis 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 hematologiclipid 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
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 lipoproteina Lpa - 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 thrombogenesisatherogenesis 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 hematologiclipid 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 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 |
|---|---|---|---|
| R01HL048259 | NIH | None | httpsreporternihgovquickSearchR01HL048259 |