- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02252900
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
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bernard IUNG, Professor
- Phone Number: 00331 40 25 67 60
- Email: bernard.iung@bch.aphp.fr
Study Contact Backup
- Name: Xavier DUVAL, Professor
- Phone Number: 00331 40 25 71 48
- Email: xavier.duval@bch.aph.fr
Study Locations
-
-
-
Paris, France, 75018
- Recruiting
- Groupe Hospitalier Bichat - Claude Bernard
-
Contact:
- Bernard IUNG, Professor
- Phone Number: 00331 40 25 67 60
- Email: bernard.iung@bch.aphp.fr
-
Contact:
- Xavier DUVAL, Professor
- Phone Number: 00331 40 25 67 76
- Email: xavier.duval@bch.aph.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Principal Investigator: Bernard IUNG, Professor, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Cardiovascular Infections
- Endocarditis, Bacterial
- Infections
- Communicable Diseases
- Endocarditis
- Endocarditis, Subacute Bacterial
Other Study ID Numbers
- P120901
- CRC12019 (OTHER: APHP)
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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