NCT05378126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

April 6, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2025

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

May 11, 2022

Last Update Submit

April 27, 2026

Conditions

EndocarditisStroke

Keywords

Neurological assessmentMedical care

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • The description of the preoperative neurological impairment

    During initial hospitalization

  • The description of the preoperative neurological impairment

    During initial hospitalization

  • The description of the perioperative hemorrhagic risk

    24 to 96 hours post-surgery

  • Prognosis assessment

    at 3 months

  • Evaluation of functional prognosis

    at 3 months

  • +2 more secondary outcomes

Study Arms (1)

Neurological cohort

OTHER

All patients included in the study wil have a neurological examination

Other: Neurological assessment

Interventions

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.

Neurological cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients
  • Certain infectious endocarditis according to Dukes Criteria
  • Signed informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stroke Unit, Pierre Wertheimer hospital, GHE Hospices Civils de Lyon

Bron, 69500, France

Location

MeSH Terms

Conditions

EndocarditisStroke

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2022

First Posted

May 18, 2022

Study Start

April 6, 2023

Primary Completion

May 22, 2025

Study Completion

May 22, 2025

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)