Long-term Clinico-radiological Evolution of Patients With Brain Lesions During Infectious Endocarditis
NCT ID: NCT02252900
Last Updated: 2016-05-10
Study Results
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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UNKNOWN
NA
130 participants
INTERVENTIONAL
2013-12-31
2018-03-31
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
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)
Magnetic resonance imaging
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
Eligibility Criteria
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Inclusion Criteria
* Cerebral MRI performed during the acute phase of endocarditis
* Resident in Metropolitan France
* 18 years old or more
Exclusion Criteria
* Contra indication to MRI scan
* History of allergy to gadolinium
* Pregnancy or lactating female
* Lack of Social Security or CMU (recipient or beneficiary)
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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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