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Thrombogenic Factors and Recurrent Coronary Events
This study has been completed.
First Received: May 25, 2000   Last Updated: June 23, 2005   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00005358
  Purpose

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
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Myocardial Infarction
Thrombosis
Death, Sudden, Cardiac

MedlinePlus related topics: Cardiac Arrest Coronary Artery Disease Heart Attack Heart Diseases
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 1994
Estimated Study Completion Date: March 1999
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005358

Sponsors and Collaborators
Investigators
Investigator: Arthur Moss University of Rochester
  More Information

Publications:
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009