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

Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05378126
• Other study ID #: 69HCL18_0798
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2023
• Est. completion date: July 2025

Study information

• Verified date: April 2023
• Source: Hospices Civils de Lyon
• Contact: Elodie ONG, Dr
• Phone: 04 72 35 78 18
• Email: elodie.ong[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endocarditis
• Stroke

Intervention

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.

Locations

Country	Name	City	State
France	Stroke Unit, Pierre Wertheimer hospital, GHE Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The description of the preoperative neurological impairment	Description of preoperative neurological impairment assessed by NIHSS score	During initial hospitalization
Secondary	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
Secondary	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
Secondary	Prognosis assessment	Evaluation of prognosis by the rate of deaths and stroke	at 3 months
Secondary	Evaluation of functional prognosis	Evaluation of the functional prognosis measured by the mRS score	at 3 months
Secondary	Evaluation of depressive anxiety disorders	Evaluation of depressive anxiety disorders measured by the Hamilton Anxiety Depression scale	at 3 months
Secondary	Evaluation of the cognitive prognosis	Evaluation of the cognitive prognosis evaluated by the MOCA score	at 3 months