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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:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00947817
First received: January 15, 2009
Last updated: May 3, 2010
Last verified: May 2010
History of Changes

January 15, 2009
May 3, 2010
September 2008
April 2010   (final data collection date for primary outcome measure)
Embolic events occurring during the antimicrobial treatment a [ Time Frame: 30 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00947817 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Impact of Endothelial Cell Activation and Modifications of Haemostasis Induced by Infective Endocarditis on the Risk of Embolism
Impact of Endothelial Cell Activation and Modifications of Haemostasis Induced by Infective Endocarditis on the Risk of Embolism.

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.
Not Provided
Interventional
Not Provided
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Infective Endocarditis
Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test
  • No Intervention: patient
    Intervention: Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test
  • No Intervention: control
    Intervention: Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00947817
2008 07, 2008-A00114-51
No
Assistance publique hopitaux de marseille, direction de la recherche 80 rue brochier 13354 marseille cedex 5
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: franck thuny Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP