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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
  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: Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Endocarditis
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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
No Intervention: patient Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test
No Intervention: control Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Assistance publique hopitaux de marseille, direction de la recherche 80 rue brochier 13354 marseille cedex 5
ClinicalTrials.gov Identifier: NCT00947817     History of Changes
Other Study ID Numbers: 2008 07, 2008-A00114-51
Study First Received: January 15, 2009
Last Updated: May 3, 2010
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Embolism
Endocarditis
Endocarditis, Bacterial
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Bacterial Infections
 Cardiovascular Infections
Infection
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013