ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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).

Condition or disease Intervention/treatment Phase
Infectious Endocarditis Other: Magnetic resonance imaging Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 130 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis

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




Primary Outcome Measures :
  1. 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 Measures :
  1. Rankin scale [ Time Frame: 1 day ]
  2. Karnofsky scale [ Time Frame: 1 day ]
  3. 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 ]
  4. IQCODE [ Time Frame: 1 day ]
  5. SF 36 [ Time Frame: 1 day ]
  6. WhOQOL [ Time Frame: 1 day ]
  7. CES-D scale [ Time Frame: 1 day ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Contacts
Contact: Bernard IUNG, Professor 00331 40 25 67 60 bernard.iung@bch.aphp.fr
Contact: Xavier DUVAL, Professor 00331 40 25 71 48 xavier.duval@bch.aph.fr

Locations
France
Groupe Hospitalier Bichat - Claude Bernard Recruiting
Paris, France, 75018
Contact: Bernard IUNG, Professor    00331 40 25 67 60    bernard.iung@bch.aphp.fr   
Contact: Xavier DUVAL, Professor    00331 40 25 67 76    xavier.duval@bch.aph.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Bernard IUNG, Professor Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02252900     History of Changes
Other Study ID Numbers: P120901
CRC12019 ( Other Identifier: APHP )
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Brain damages
MRI
infectious endocarditis

Additional relevant MeSH terms:
Communicable Diseases
Infection
Endocarditis
Endocarditis, Subacute Bacterial
Endocarditis, Bacterial
Bacterial Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Cardiovascular Infections
Heart Diseases
Cardiovascular Diseases