Evaluation of the Prognostic Impact of a Neuro-vascular Examination Associated With Cerebral MRI in the Acute Phase of Infectious Endocarditis (POMPEI)
Primary Purpose
Endocarditis, Stroke
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neurological assessment
Sponsored by
About this trial
This is an interventional health services research trial for Endocarditis focused on measuring Neurological assessment, Medical care
Eligibility Criteria
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.
Sites / Locations
- Stroke Unit, Pierre Wertheimer hospital, GHE Hospices Civils de LyonRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Neurological cohort
Arm Description
All patients included in the study wil have a neurological examination
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
The description of the preoperative neurological impairment
Description of preoperative neurological impairment assessed by NIHSS score
The description of the preoperative neurological impairment
Description of preoperative neurological impairment assessed by the presence of brain lesions on initial MRI
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
Prognosis assessment
Evaluation of prognosis by the rate of deaths and stroke
Evaluation of functional prognosis
Evaluation of the functional prognosis measured by the mRS score
Evaluation of depressive anxiety disorders
Evaluation of depressive anxiety disorders measured by the Hamilton Anxiety Depression scale
Evaluation of the cognitive prognosis
Evaluation of the cognitive prognosis evaluated by the MOCA score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05378126
Brief Title
Evaluation of the Prognostic Impact of a Neuro-vascular Examination Associated With Cerebral MRI in the Acute Phase of Infectious Endocarditis
Acronym
POMPEI
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocarditis, Stroke
Keywords
Neurological assessment, Medical care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neurological cohort
Arm Type
Other
Arm Description
All patients included in the study wil have a neurological examination
Intervention Type
Other
Intervention Name(s)
Neurological assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medical care modification
Description
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.
Time Frame
at 3 months
Title
Medical care modification
Description
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.
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
The description of the preoperative neurological impairment
Description
Description of preoperative neurological impairment assessed by NIHSS score
Time Frame
During initial hospitalization
Title
The description of the preoperative neurological impairment
Description
Description of preoperative neurological impairment assessed by the presence of brain lesions on initial MRI
Time Frame
During initial hospitalization
Title
The description of the perioperative hemorrhagic risk
Description
Description of the perioperative hemorrhagic risk evaluated by the rate of haemorrhagic transformation on the post-surgery control scanner
Time Frame
24 to 96 hours post-surgery
Title
Prognosis assessment
Description
Evaluation of prognosis by the rate of deaths and stroke
Time Frame
at 3 months
Title
Evaluation of functional prognosis
Description
Evaluation of the functional prognosis measured by the mRS score
Time Frame
at 3 months
Title
Evaluation of depressive anxiety disorders
Description
Evaluation of depressive anxiety disorders measured by the Hamilton Anxiety Depression scale
Time Frame
at 3 months
Title
Evaluation of the cognitive prognosis
Description
Evaluation of the cognitive prognosis evaluated by the MOCA score
Time Frame
at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie ONG, Dr
Phone
04 72 35 78 18
Ext
+33
Email
elodie.ong@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julia CANTERINI
Phone
04 27 85 66 28
Ext
+33
Email
julia.canterini@chu-lyon.fr
Facility Information:
Facility Name
Stroke Unit, Pierre Wertheimer hospital, GHE Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elodie ONG
Phone
04 72 35 78 18
Ext
+33
Email
elodie.ong@chu-lyon.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Prognostic Impact of a Neuro-vascular Examination Associated With Cerebral MRI in the Acute Phase of Infectious Endocarditis
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