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

Not Applicable

Recruiting

• Conditions: Endocarditis; Stroke
• Interventions: Other: Neurological assessment

• Registration Number: NCT05378126
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-17
• Study First Posted: 2022-05-18
• Status Verified: 2023-04
• Study Start: 2023-04-06
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurological cohort	Neurological assessment	All patients included in the study wil have a neurological examination

Primary Outcome Measures

Name	Time	Method
Medical care modification	at 3 months	Description of the medical care modification after neurological assessment, evaluated by the number of patients with modified medical care by the change of therapy compared to the initially scheduled care.

Secondary Outcome Measures

Name	Time	Method
The description of the preoperative neurological impairment	During initial hospitalization	Description of preoperative neurological impairment assessed by the presence of brain lesions on initial MRI
Evaluation of depressive anxiety disorders	at 3 months	Evaluation of depressive anxiety disorders measured by the Hamilton Anxiety Depression scale
Prognosis assessment	at 3 months	Evaluation of prognosis by the rate of deaths and stroke
The description of the perioperative hemorrhagic risk	24 to 96 hours post-surgery	Description of the perioperative hemorrhagic risk evaluated by the rate of haemorrhagic transformation on the post-surgery control scanner
Evaluation of functional prognosis	at 3 months	Evaluation of the functional prognosis measured by the mRS score
Evaluation of the cognitive prognosis	at 3 months	Evaluation of the cognitive prognosis evaluated by the MOCA score

Trial Locations

Locations (1)

Stroke Unit, Pierre Wertheimer hospital, GHE Hospices Civils de Lyon; 🇫🇷 Bron, France