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临床试验/NCT05378126
NCT05378126已完成不适用

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 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2023年4月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Medical care modification

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Neurological cohort

Other

All patients included in the study wil have a neurological examination

干预措施: Neurological assessment (Other)

结局指标

主要结局

Medical care modification

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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