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

Infectious Endocarditis Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02252900
• Other study ID #: P120901
• Secondary ID: CRC12019
• Status: Recruiting
• Phase: N/A
• First received: December 19, 2013
• Last updated: May 9, 2016
• Start date: December 2013
• Est. completion date: March 2018

Study information

• Verified date: May 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Bernard IUNG, Professor
• Phone: 00331 40 25 67 60
• Email: bernard.iung[@]bch.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Communicable Diseases
• Endocarditis
• Infection
• Infectious Endocarditis

Intervention

Other:
• Magnetic resonance imaging
All patients will undergo the diagnostic test specific to the study

Locations

Country	Name	City	State
France	Groupe Hospitalier Bichat - Claude Bernard	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Rankin scale		1 day	No
Secondary	Karnofsky scale		1 day	No
Secondary	Neuropsychologic tests to assess cognitive, executive, language and memory functions (including MMS, BREF, Trail making test, Wisconsin card sorting test, STROOP)		1 day	No
Secondary	IQCODE		1 day	No
Secondary	SF 36		1 day	No
Secondary	WhOQOL		1 day	No
Secondary	CES-D scale		1 day	No