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

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

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).

Study Overview

Status

Unknown

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Paris, France, 75018
        • Recruiting
        • Groupe Hospitalier Bichat - Claude Bernard
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: cerebral MRI during follow-up of IE
All patients will undergo the diagnostic test specific to the study (Magnetic resonance imaging)
All patients will undergo the diagnostic test specific to the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 1 day
1 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bernard IUNG, Professor, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

March 1, 2018

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

September 26, 2014

First Posted (ESTIMATE)

September 30, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 9, 2016

Last Verified

May 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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