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Impact of Endothelial Cell Activation and Modifications of Haemostasis Induced by Infective Endocarditis on the Risk of Embolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00947817
First Posted: July 28, 2009
Last Update Posted: August 24, 2015
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.
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
  Purpose
Prospective study including all the consecutive patients admitted at the Department of Cardiology, Timone Hospital wih a definite diagnosis of IE according to the modified Duke criteria. The period of inclusion will be for 24 months. Eighty patients and age-matched control subject will be included. Primary end point are EE occurring during the antimicrobial treatment and secondary end points will be 6-month mortality, vegetation length and the impact of antimicrobial treatment on inflammation-induced procoagulant changes and endothelial cell activation.

Condition Intervention
Infective Endocarditis Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Endothelial Cell Activation and Modifications of Haemostasis Induced by Infective Endocarditis on the Risk of Embolism.

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • Embolic events occurring during the antimicrobial treatment a [ Time Frame: 30 months ]

Secondary Outcome Measures:
  • Will be 6-month mortality, vegetation length and the impact of antimicrobial treatment on inflammation-induced procoagulant changes and endothelial cell activation. [ Time Frame: 30months ]

Enrollment: 77
Study Start Date: September 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patient Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test
control Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All the patients presenting certain diagnosis of infectious endocardite according to the criteria of modified Duke

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy and feeding
  • Health not allowing to give the assent
  • Innate abnormalities of the haemostasis
  • More than a week before the inclu antibiothérapie adapted begun
  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): NCT00947817


Locations
France
Département de Cardiologie, Unité Valvulopathies et Insuffisance Cardiaque, Hôpital de la Timone,
Marseille, Paca, France, 13
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: franck thuny Assistance Publique Hopitaux De Marseille
  More Information

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00947817     History of Changes
Other Study ID Numbers: 2008 07
2008-A00114-51
First Submitted: January 15, 2009
First Posted: July 28, 2009
Last Update Posted: August 24, 2015
Last Verified: May 2010

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Bacterial
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Bacterial Infections
Cardiovascular Infections
Infection
Hemostatics
Coagulants