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.

Study Overview

• Status: Completed
• Conditions: Infective Endocarditis
• Intervention / Treatment: Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paca
    • Marseille, Paca, France, 13
      • Département de Cardiologie, Unité Valvulopathies et Insuffisance Cardiaque, Hôpital de la Timone,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patient	Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test
Other: control	Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Embolic events occurring during the antimicrobial treatment a	30 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Principal Investigator: franck thuny, Assistance Publique Hopitaux de Marseille

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: January 15, 2009
• First Submitted That Met QC Criteria: July 27, 2009
• First Posted (Estimate): July 28, 2009

Study Record Updates

• Last Update Posted (Estimate): August 24, 2015
• Last Update Submitted That Met QC Criteria: August 21, 2015
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infections; Embolism and Thrombosis; Bacterial Infections; Bacterial Infections and Mycoses; Cardiovascular Infections; Embolism; Endocarditis, Bacterial; Endocarditis
• Other Study ID Numbers: 2008 07; 2008-A00114-51