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Thrombogenic Factors and Recurrent Coronary Events

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005358
First Posted: May 26, 2000
Last Update Posted: January 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of Rochester
  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

Study Type: Observational

Further study details as provided by University of Rochester:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005358


Sponsors and Collaborators
University of Rochester
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Arthur Moss University of Rochester
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005358     History of Changes
Other Study ID Numbers: 4245
R01HL048259 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2000
First Posted: May 26, 2000
Last Update Posted: January 15, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Thrombosis
Coronary Disease
Coronary Artery Disease
Death, Sudden
Death, Sudden, Cardiac
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Embolism and Thrombosis
Arteriosclerosis
Arterial Occlusive Diseases
Death
Heart Arrest