Evaluation of the Prognostic Impact of a Neuro-vascular Examination Associated with Cerebral MRI in the Acute Phase of Infectious Endocarditis

NCT ID: NCT05378126

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-06

Study Completion Date

2026-07-31

Brief Summary

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Infectious endocarditis (IE) is a serious condition with an annual incidence of 3 to 10 per 100,000 people. Brain infarctions complicate approximately 20-40% of endocarditis.

Brain MRI can detect the presence of recent ischemic lesions and asymptomatic microbleeds. Preoperative brain imaging is part of the recommended assessment in the management of IEs, but the type of imaging and sequences are not codified and the impact of cerebral and vascular imaging findings on the therapeutic decision remains uncertain.

The level of evidence of the recommendations remains low, especially for complicated IEs of stroke. There is very little neurological clinical data on patients with IEs. Similarly, neurologists do not systematically participate in multidisciplinary meetings during the management of an IE. It therefore seems interesting to carry out a neurological cohort of this population and to evaluate what would be the contribution of vascular neurologists in the management of infectious endocarditis.

Detailed Description

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Conditions

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Endocarditis Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Neurological cohort

All patients included in the study wil have a neurological examination

Group Type OTHER

Neurological assessment

Intervention Type OTHER

No specific procedure is planned for the study other than the neurological examination by a neurologist of all patients. The patient will be taken care according to current recommendations.

In addition, a study-specific, non-injected brain CT scan will be performed systematically in patients undergoing cardiac surgery to evaluate postoperative hemorrhagic transformation.

Interventions

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Neurological assessment

No specific procedure is planned for the study other than the neurological examination by a neurologist of all patients. The patient will be taken care according to current recommendations.

In addition, a study-specific, non-injected brain CT scan will be performed systematically in patients undergoing cardiac surgery to evaluate postoperative hemorrhagic transformation.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients
* Certain infectious endocarditis according to Dukes Criteria
* Signed informed consent

Exclusion Criteria

* Hospital admission due to neurovascular emergency
* MRI contraindications
* Pregnant or women of childbearing age who were not using contraception (oral diagnosis),
* Patient without health coverage,
* Patient under legal protection.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stroke Unit, Pierre Wertheimer hospital, GHE Hospices Civils de Lyon

Bron, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Elodie ONG, Dr

Role: CONTACT

04 72 35 78 18 ext. +33

Julia CANTERINI

Role: CONTACT

04 27 85 66 28 ext. +33

Facility Contacts

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Elodie ONG

Role: primary

04 72 35 78 18 ext. +33

Other Identifiers

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69HCL18_0798

Identifier Type: -

Identifier Source: org_study_id

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