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

Infectious Endocarditis Clinical Trial

Official title: Long-term Clinico-radiological Evolution of Patients With Symptomatic and Asymptomatic Brain Lesions During Infectious Endocarditis

Status Recruiting

Clinical Trial 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).

Clinical Trial 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Communicable Diseases
• Endocarditis
• Infection
• Infectious Endocarditis

• NCT number: NCT02252900
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Bernard IUNG, Professor
• Phone: 00331 40 25 67 60
• Email: bernard.iung@bch.aphp.fr
• Status: Recruiting
• Phase: N/A
• Start date: December 2013
• Completion date: March 2018