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

NCT ID: NCT00947817

Last Updated: 2015-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-04-30

Brief Summary

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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

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Conditions

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Infective Endocarditis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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patient

Group Type EXPERIMENTAL

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

Intervention Type OTHER

control

Group Type OTHER

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

Intervention Type OTHER

Interventions

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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franck thuny

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hopitaux De Marseille

Locations

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

Marseille, Paca, France

Site Status

Countries

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France

Other Identifiers

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2008-A00114-51

Identifier Type: -

Identifier Source: secondary_id

2008 07

Identifier Type: -

Identifier Source: org_study_id

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