Long-term Clinico-radiological Evolution of Patients With Brain Lesions During Infectious Endocarditis (POST-IMAGE)
Primary Purpose
Infectious Endocarditis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetic resonance imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Infectious Endocarditis focused on measuring Brain damages, MRI, infectious endocarditis
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)
Sites / Locations
- Groupe Hospitalier Bichat - Claude BernardRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cerebral MRI during follow-up of IE
Arm Description
All patients will undergo the diagnostic test specific to the study (Magnetic resonance imaging)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Rankin scale
Karnofsky scale
Neuropsychologic tests to assess cognitive, executive, language and memory functions (including MMS, BREF, Trail making test, Wisconsin card sorting test, STROOP)
IQCODE
SF 36
WhOQOL
CES-D scale
Full Information
NCT ID
NCT02252900
First Posted
December 19, 2013
Last Updated
May 9, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT02252900
Brief Title
Long-term Clinico-radiological Evolution of Patients With Brain Lesions During Infectious Endocarditis
Acronym
POST-IMAGE
Official Title
Long-term Clinico-radiological Evolution of Patients With Symptomatic and Asymptomatic Brain Lesions During Infectious Endocarditis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Endocarditis
Keywords
Brain damages, MRI, infectious endocarditis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cerebral MRI during follow-up of IE
Arm Type
Experimental
Arm Description
All patients will undergo the diagnostic test specific to the study (Magnetic resonance imaging)
Intervention Type
Other
Intervention Name(s)
Magnetic resonance imaging
Intervention Description
All patients will undergo the diagnostic test specific to the study
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Rankin scale
Time Frame
1 day
Title
Karnofsky scale
Time Frame
1 day
Title
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
Title
IQCODE
Time Frame
1 day
Title
SF 36
Time Frame
1 day
Title
WhOQOL
Time Frame
1 day
Title
CES-D scale
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernard IUNG, Professor
Phone
00331 40 25 67 60
Email
bernard.iung@bch.aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier DUVAL, Professor
Phone
00331 40 25 71 48
Email
xavier.duval@bch.aph.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard IUNG, Professor
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard IUNG, Professor
Phone
00331 40 25 67 60
Email
bernard.iung@bch.aphp.fr
First Name & Middle Initial & Last Name & Degree
Xavier DUVAL, Professor
Phone
00331 40 25 67 76
Email
xavier.duval@bch.aph.fr
12. IPD Sharing Statement
Learn more about this trial
Long-term Clinico-radiological Evolution of Patients With Brain Lesions During Infectious Endocarditis
We'll reach out to this number within 24 hrs