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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02252900
Other study ID # P120901
Secondary ID CRC12019
Status Recruiting
Phase N/A
First received December 19, 2013
Last updated May 9, 2016
Start date December 2013
Est. completion date March 2018

Study information

Verified date May 2016
Source Assistance Publique - Hôpitaux de Paris
Contact Bernard IUNG, Professor
Phone 00331 40 25 67 60
Email bernard.iung@bch.aphp.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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).


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


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date March 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

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

Locations

Country Name City State
France Groupe Hospitalier Bichat - Claude Bernard Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 day No
Secondary Rankin scale 1 day No
Secondary Karnofsky scale 1 day No
Secondary Neuropsychologic tests to assess cognitive, executive, language and memory functions (including MMS, BREF, Trail making test, Wisconsin card sorting test, STROOP) 1 day No
Secondary IQCODE 1 day No
Secondary SF 36 1 day No
Secondary WhOQOL 1 day No
Secondary CES-D scale 1 day No
See also
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Recruiting NCT04691440 - Hyperbaric Oxygen Treatment in Humans With Gram Positive Cocci Endocarditis Phase 2
Completed NCT03681431 - Evaluation of an Antibiotic Regimen Pharmacokinetic Applicable to Enterococcus Faecalis Infective Endocarditis Phase 2