Trials / Completed
CompletedNCT00005358
Thrombogenic Factors and Recurrent Coronary Events
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- —
- Sponsor
- University of Rochester · Academic / Other
- Sex
- Male
- Age
- 100 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Cardiovascular Diseases
- Heart Diseases
- Coronary Disease
- Myocardial Infarction
- Thrombosis
- Death, Sudden, Cardiac
Timeline
- Start date
- 1994-04-01
- Completion
- 1999-03-01
- First posted
- 2000-05-26
- Last updated
- 2016-01-15
Source: ClinicalTrials.gov record NCT00005358. Inclusion in this directory is not an endorsement.