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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00005358 |
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.
Condition |
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Cardiovascular Diseases Heart Diseases Coronary Disease Myocardial Infarction Thrombosis Death, Sudden, Cardiac |
Study Type: | Observational |
Study Design: | Natural History |
Study Start Date: | April 1994 |
Estimated Study Completion Date: | March 1999 |
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.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 4245 |
Study First Received: | May 25, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00005358 History of Changes |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Death Heart Diseases Myocardial Ischemia Vascular Diseases Heart Arrest Arteriosclerosis Ischemia Thrombosis Recurrence |
Coronary Disease Embolism and Thrombosis Necrosis Embolism Death, Sudden Death, Sudden, Cardiac Infarction Myocardial Infarction Coronary Artery Disease |
Arterial Occlusive Diseases Death Heart Diseases Myocardial Ischemia Vascular Diseases Heart Arrest Ischemia Arteriosclerosis Thrombosis Coronary Disease |
Embolism and Thrombosis Necrosis Pathologic Processes Death, Sudden Cardiovascular Diseases Death, Sudden, Cardiac Infarction Myocardial Infarction Coronary Artery Disease |