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

Not Applicable

• Conditions: Infectious Endocarditis
• Interventions: Other: Magnetic resonance imaging

• Registration Number: NCT02252900
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-09-30
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-09
• Last Update Posted: 2016-05-10
• Primary Completion: 2017-12
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cerebral MRI during follow-up of IE	Magnetic resonance imaging	All patients will undergo the diagnostic test specific to the study (Magnetic resonance imaging)

Primary Outcome Measures

Name	Time	Method
Comparison of the proportion of patients with abnormal cerebral MRI (ischemic or haemorrhagic lesion, infection and cerebral aneurysm) detected at the initial evaluation during the IE acute phase and at the follow-up visit	1 day

Secondary Outcome Measures

Name	Time	Method
CES-D scale	1 day
Rankin scale	1 day
Karnofsky scale	1 day
SF 36	1 day
IQCODE	1 day
WhOQOL	1 day
Neuropsychologic tests to assess cognitive, executive, language and memory functions (including MMS, BREF, Trail making test, Wisconsin card sorting test, STROOP)	1 day

Trial Locations

Locations (1)

Groupe Hospitalier Bichat - Claude Bernard; 🇫🇷 Paris, France