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Clinical Trials/NCT05378126
NCT05378126
Completed
Not Applicable

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

Hospices Civils de Lyon2 sites in 1 country29 target enrollmentApril 6, 2023

Overview

Phase
Not Applicable
Intervention
Neurological assessment
Conditions
Endocarditis
Sponsor
Hospices Civils de Lyon
Enrollment
29
Locations
2
Primary Endpoint
Medical care modification
Status
Completed
Last Updated
yesterday

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 6, 2023
End Date
May 22, 2025
Last Updated
yesterday
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Arms & Interventions

Neurological cohort

All patients included in the study wil have a neurological examination

Intervention: Neurological assessment

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Evaluation of depressive anxiety disorders(at 3 months)
  • Prognosis assessment(at 3 months)
  • The description of the perioperative hemorrhagic risk(24 to 96 hours post-surgery)
  • Evaluation of functional prognosis(at 3 months)
  • Evaluation of the cognitive prognosis(at 3 months)
  • The description of the preoperative neurological impairment(During initial hospitalization)

Study Sites (2)

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