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Long-term Clinico-radiological Evolution of Patients With Brain Lesions During Infectious Endocarditis

Long-term Clinico-radiological Evolution of Patients With Symptomatic and Asymptomatic Brain Lesions During Infectious Endocarditis

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02252900
Acronym
POST-IMAGE
Enrollment
100
Registered
2014-09-30
Start date
2013-12-12
Completion date
2017-07-06
Last updated
2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Endocarditis

Keywords

Brain damages, MRI, infectious endocarditis

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

Interventions

OTHERMagnetic resonance imaging

All patients will undergo the diagnostic test specific to the study

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime 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 visit1 day

Secondary

MeasureTime frame
Rankin scale1 day
Karnofsky scale1 day
Neuropsychologic tests to assess cognitive, executive, language and memory functions (including MMS, BREF, Trail making test, Wisconsin card sorting test, STROOP)1 day
IQCODE1 day
SF 361 day
WhOQOL1 day
CES-D scale1 day

Countries

France

Contacts

PRINCIPAL_INVESTIGATORBernard IUNG, Professor

Assistance Publique Hopitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026