Long-term Clinico-radiological Evolution of Patients With Brain Lesions During Infectious Endocarditis

NCT ID: NCT02252900

Last Updated: 2016-05-10

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2018-03-31

Brief Summary

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Primary objective: To describe the evolution of cerebral lesions in IE patients (number of patients with abnormal cerebral MRI in acute phase of IE and during follow-up).

Detailed Description

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Introduction:

Infectious endocarditis (IE) is a rare disease (1500 cases per year in France) with a poor prognosis (20 % of mortality). Neurological complications participate in the initial morbimortality but their long-term impact is poorly known. The acute neurological complications are symptomatic in approximately a quarter of patients. Neurological lesions are frequently observed using systematic cerebral imaging. In the IMAGE study, systematic cerebral MRI in 130 patients performed during the acute phase of IE allowed found cerebral lesion in 82 % of the patients and in 79 % of patients without neurological symptoms. The evolution of cerebral lesion, including brain micro-bleedings and their impact prognosis are not known.

Hypothesis: Cerebral lesions detected by MRI during the acute phase of infectious endocarditis may involve and may have an impact on functional prognosis.

Primary objective: To describe the evolution of cerebral lesions in IE patients (comparing the proportion of patients with abnormal cerebral MRI in acute phase of IE and during follow-up).

Secondary objectives:

* To compare frequency of different brain damages in acute phase of IE and during follow-up.
* To analyse the relationship between functional and cognitive status and cerebral lesions.
* To analyse the relationship between initial and follow-up cerebral lesions and initials characteristics (microorganisms, anticoagulation, echocardiographic characteristics, valve replacement surgery, type of valvular substitute, mycotic aneurysm embolization)
* To collect plasma during follow-up of IE
* To compare patient characteristics between patients who accept the functional exploration and those who patient refuse
* To describe oral health and oral condition

Conditions

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Infectious Endocarditis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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cerebral MRI during follow-up of IE

All patients will undergo the diagnostic test specific to the study (Magnetic resonance imaging)

Group Type EXPERIMENTAL

Magnetic resonance imaging

Intervention Type OTHER

All patients will undergo the diagnostic test specific to the study

Interventions

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Magnetic resonance imaging

All patients will undergo the diagnostic test specific to the study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* History of Infective endocarditis treated in Bichat Claude Bernard hospital
* Cerebral MRI performed during the acute phase of endocarditis
* Resident in Metropolitan France
* 18 years old or more

Exclusion Criteria

* Refusal to participate
* Contra indication to MRI scan
* History of allergy to gadolinium
* Pregnancy or lactating female
* Lack of Social Security or CMU (recipient or beneficiary)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernard IUNG, Professor

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Groupe Hospitalier Bichat - Claude Bernard

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Bernard IUNG, Professor

Role: CONTACT

00331 40 25 67 60

Xavier DUVAL, Professor

Role: CONTACT

00331 40 25 71 48

Facility Contacts

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Bernard IUNG, Professor

Role: primary

00331 40 25 67 60

Xavier DUVAL, Professor

Role: backup

00331 40 25 67 76

Other Identifiers

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CRC12019

Identifier Type: OTHER

Identifier Source: secondary_id

P120901

Identifier Type: -

Identifier Source: org_study_id

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