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

Infective Endocarditis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947817
• Other study ID #: 2008 07
• Secondary ID: 2008-A00114-51
• Status: Completed
• Phase: N/A
• First received: January 15, 2009
• Last updated: August 21, 2015
• Start date: September 2008
• Est. completion date: April 2010

Study information

• Verified date: May 2010
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Intervention

Other:
• ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test

Locations

Country	Name	City	State
France	Département de Cardiologie, Unité Valvulopathies et Insuffisance Cardiaque, Hôpital de la Timone,	Marseille	Paca

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Embolic events occurring during the antimicrobial treatment a		30 months	No
Secondary	Will be 6-month mortality, vegetation length and the impact of antimicrobial treatment on inflammation-induced procoagulant changes and endothelial cell activation.		30months	No