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Completed

NCT Number: NCT05378126

Evaluation of 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.

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Key information

Conditions

Endocarditis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurological assessment

Other

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. The description of the preoperative neurological impairment

    Time frame: During initial hospitalization

    Description of preoperative neurological impairment assessed by NIHSS score

  2. The description of the preoperative neurological impairment

    Time frame: During initial hospitalization

    Description of preoperative neurological impairment assessed by the presence of brain lesions on initial MRI

  3. The description of the perioperative hemorrhagic risk

    Time frame: 24 to 96 hours post-surgery

    Description of the perioperative hemorrhagic risk evaluated by the rate of haemorrhagic transformation on the post-surgery control scanner

  4. Prognosis assessment

    Time frame: at 3 months

    Evaluation of prognosis by the rate of deaths and stroke

  5. Evaluation of functional prognosis

    Time frame: at 3 months

    Evaluation of the functional prognosis measured by the mRS score

  6. Evaluation of depressive anxiety disorders

    Time frame: at 3 months

    Evaluation of depressive anxiety disorders measured by the Hamilton Anxiety Depression scale

  7. Evaluation of the cognitive prognosis

    Time frame: at 3 months

    Evaluation of the cognitive prognosis evaluated by the MOCA score

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: POMPEI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 18, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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