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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Endocarditis
• Intervention / Treatment: Other: Neurological assessment

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Stroke Unit, Pierre Wertheimer hospital, GHE Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Neurological cohort; All patients included in the study wil have a neurological examination

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical care modification	Description 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.	at 3 months
Medical care modification	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.	at 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Actual): May 22, 2025
• Study Completion (Actual): May 22, 2025

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Neurological assessment; Medical care
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Stroke; Endocarditis
• Other Study ID Numbers: 69HCL18_0798

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No