Clinical trial NCT02252900: Long-term Clinico-radiological Evolution of Patients With Brain Lesions During Infectious Endocarditis
Official title: Long-term Clinico-radiological Evolution of Patients With Symptomatic and Asymptomatic Brain Lesions During Infectious Endocarditis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infectious Endocarditis
Keywords: Brain damages
MRI
infectious endocarditis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-09-30
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: 1 day
Secondary outcomes:
measure: Rankin scale
timeFrame: 1 day
measure: Karnofsky scale
timeFrame: 1 day
measure: Neuropsychologic tests to assess cognitive, executive, language and memory functions (including MMS, BREF, Trail making test, Wisconsin card sorting test, STROOP)
timeFrame: 1 day
measure: IQCODE
timeFrame: 1 day
measure: SF 36
timeFrame: 1 day
measure: WhOQOL
timeFrame: 1 day
measure: CES-D scale
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Bichat - Claude Bernard
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Bernard IUNG, Professor
role: PRINCIPAL_INVESTIGATOR
References: