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

Prospective Pilot Study Evaluating the Prognostic Impact of a Neuro-vascular Examination Associated with Cerebral MRI in the Acute Phase of Infectious Endocarditis

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05378126
Acronym
POMPEI
Enrollment
110
Registered
2022-05-18
Start date
2023-04-06
Completion date
2026-07-31
Last updated
2025-03-30

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

Conditions

Endocarditis, Stroke

Keywords

Neurological assessment, Medical care

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.

Interventions

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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Medical care modificationat 3 monthsDescription of the medical care modification after neurological assessment, evaluated by the number of patients with modified medical care by the request for a new examination compared to the initially scheduled care.

Secondary

MeasureTime frameDescription
The description of the perioperative hemorrhagic risk24 to 96 hours post-surgeryDescription of the perioperative hemorrhagic risk evaluated by the rate of haemorrhagic transformation on the post-surgery control scanner
Prognosis assessmentat 3 monthsEvaluation of prognosis by the rate of deaths and stroke
The description of the preoperative neurological impairmentDuring initial hospitalizationDescription of preoperative neurological impairment assessed by NIHSS score
Evaluation of depressive anxiety disordersat 3 monthsEvaluation of depressive anxiety disorders measured by the Hamilton Anxiety Depression scale
Evaluation of the cognitive prognosisat 3 monthsEvaluation of the cognitive prognosis evaluated by the MOCA score
Evaluation of functional prognosisat 3 monthsEvaluation of the functional prognosis measured by the mRS score

Countries

France

Contacts

Primary ContactElodie ONG, Dr
elodie.ong@chu-lyon.fr04 72 35 78 18
Backup ContactJulia CANTERINI
julia.canterini@chu-lyon.fr04 27 85 66 28

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026