Long-term Clinico-radiological Evolution of Patients With Brain Lesions During Infectious Endocarditis (POST-IMAGE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02252900|
Recruitment Status : Unknown
Verified May 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : September 30, 2014
Last Update Posted : May 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Infectious Endocarditis||Other: Magnetic resonance imaging||Not Applicable|
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).
- 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 (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-term Clinico-radiological Evolution of Patients With Symptomatic and Asymptomatic Brain Lesions During Infectious Endocarditis|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||March 2018|
Experimental: cerebral MRI during follow-up of IE
All patients will undergo the diagnostic test specific to the study (Magnetic resonance imaging)
Other: Magnetic resonance imaging
All patients will undergo the diagnostic test specific to the study
- 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 ]
- Rankin scale [ Time Frame: 1 day ]
- Karnofsky scale [ Time Frame: 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 ]
- IQCODE [ Time Frame: 1 day ]
- SF 36 [ Time Frame: 1 day ]
- WhOQOL [ Time Frame: 1 day ]
- CES-D scale [ Time Frame: 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252900
|Contact: Bernard IUNG, Professor||00331 40 25 67 email@example.com|
|Contact: Xavier DUVAL, Professor||00331 40 25 71 firstname.lastname@example.org|
|Groupe Hospitalier Bichat - Claude Bernard||Recruiting|
|Paris, France, 75018|
|Contact: Bernard IUNG, Professor 00331 40 25 67 60 email@example.com|
|Contact: Xavier DUVAL, Professor 00331 40 25 67 76 firstname.lastname@example.org|
|Principal Investigator:||Bernard IUNG, Professor||Assistance Publique - Hôpitaux de Paris|