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

Not Applicable

Completed

• Conditions: Infective Endocarditis
• Interventions: Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test

• Registration Number: NCT00947817
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-07-27
• Study First Posted: 2009-07-28
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-05
• Last Update Submitted: 2015-08-21
• Last Update Posted: 2015-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test	-
patient	ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test	-

Primary Outcome Measures

Name	Time	Method
Embolic events occurring during the antimicrobial treatment a	30 months

Secondary Outcome Measures

Name	Time	Method
Will be 6-month mortality, vegetation length and the impact of antimicrobial treatment on inflammation-induced procoagulant changes and endothelial cell activation.	30months

Trial Locations

Locations (1)

Département de Cardiologie, Unité Valvulopathies et Insuffisance Cardiaque, Hôpital de la Timone,; 🇫🇷 Marseille, Paca, France