EndocarditisPOMPEINCT05378126
Evaluation of the Prognostic Impact of a Neuro-vascular Examination Associated With Cerebral MRI in the Acute Phase of Infectious Endocarditis
A study testing Neurological assessment in people with Endocarditis and Stroke, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocarditis, Stroke
- What is being tested?
- Neurological assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2023to 22 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Certain infectious endocarditis according to Dukes Criteria
- Signed informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Stroke Unit, Pierre Wertheimer hospital, GHE Hospices Civils de Lyon
Bron, 69500
About this study
Official title: 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.
- Conditions
- Endocarditis, Stroke
- Being tested
- Neurological assessment
- Keywords
- Neurological assessment, Medical care
- Medical subject headings
- Endocarditis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Neurological cohort | Other | All patients included in the study wil have a neurological examination Receives: Other: Neurological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at 3 months
Secondary outcomes (7)
The description of the preoperative neurological impairment
Description of preoperative neurological impairment assessed by NIHSS score
Measured: 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
Measured: 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
Measured: 24 to 96 hours post-surgery
Prognosis assessment
Evaluation of prognosis by the rate of deaths and stroke
Measured: at 3 months
Evaluation of functional prognosis
Evaluation of the functional prognosis measured by the mRS score
Measured: at 3 months
Evaluation of depressive anxiety disorders
Evaluation of depressive anxiety disorders measured by the Hamilton Anxiety Depression scale
Measured: at 3 months
Evaluation of the cognitive prognosis
Evaluation of the cognitive prognosis evaluated by the MOCA score
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start6 Apr 2023
- Primary completion22 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndocarditisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378126
- Sponsor's protocol ID
- 69HCL18_0798
- Acronym
- POMPEI
- Status last verified
- Apr 2026
- First submitted
- 11 May 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study Evaluating the Prognostic Impact of a Neuro-vascular Examination Associated With Cerebral MRI in the Acute Phase of Infectious Endocarditis
- ClinicalTrials.gov ID
- NCT05378126
- Acronym / sponsor ID
- POMPEI / 69HCL18_0798
- Conditions
- Endocarditis, Stroke
- Keywords
- Neurological assessment, Medical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurological cohort | Other | Other: Neurological assessmentAll patients included in the study wil have a neurological examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- Certain infectious endocarditis according to Dukes Criteria
- Signed informed consent
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurological assessmentNo 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. | Other | Neurological cohort |
Primary outcome
Medical care modification
Time frame: at 3 months
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.
Medical care modification
Time frame: 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.
7 secondary outcomes
The description of the preoperative neurological impairment
Time frame: During initial hospitalization
The description of the preoperative neurological impairment
Time frame: During initial hospitalization
The description of the perioperative hemorrhagic risk
Time frame: 24 to 96 hours post-surgery
Prognosis assessment
Time frame: at 3 months
Evaluation of functional prognosis
Time frame: at 3 months
Evaluation of depressive anxiety disorders
Time frame: at 3 months
Evaluation of the cognitive prognosis
Time frame: at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurological assessment in people with Endocarditis and Stroke, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical care modification (time frame: at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.