Long-term Clinico-radiological Evolution of Patients With Brain Lesions During Infectious Endocarditis (POST-IMAGE)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Infectious Endocarditis

Treatments: Other: Magnetic resonance imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02252900

CRC12019 (Other Identifier)

P120901

Details and patient eligibility

About

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).

Full 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

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

cerebral MRI during follow-up of IE

Experimental group

Description:

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

Treatment:

Other: Magnetic resonance imaging