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

Primary Purpose

Infective Endocarditis

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test

About this trial

This is an interventional prevention trial for Infective Endocarditis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Département de Cardiologie, Unité Valvulopathies et Insuffisance Cardiaque, Hôpital de la Timone,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

patient

control

Arm Description

Outcomes

Primary Outcome Measures

Embolic events occurring during the antimicrobial treatment a

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.

Full Information

NCT ID

NCT00947817

First Posted

January 15, 2009

Last Updated

August 21, 2015

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT00947817

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infective Endocarditis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

patient

Arm Type

Experimental

Arm Title

control

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test

Primary Outcome Measure Information:

Title

Embolic events occurring during the antimicrobial treatment a

Time Frame

30 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

franck thuny

Organizational Affiliation

Assistance Publique Hopitaux De Marseille

Official's Role

Principal Investigator

Facility Information:

Facility Name

Département de Cardiologie, Unité Valvulopathies et Insuffisance Cardiaque, Hôpital de la Timone,

City

Marseille

State/Province

Paca

ZIP/Postal Code

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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