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临床试验/NCT05553990
NCT05553990招募中不适用

Predictive Value of Human Microbiome and Serological Markers for Clinical Outcome of Acute Ischemic Stroke With Active Cancer

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Neurological function score (mRS score)

研究概览

简要总结

Explore with active cancer patients with acute ischemic stroke in the human body characteristic microorganism disorder to clinical prognosis of the predictive value of the secondary objective: to observe with active cancer patients with acute ischemic stroke in the body of microorganisms and their serological indexes change law of exploration condition change related biomarkers of microscopic objects group based on the human body.

详细描述

investigators recently found that changes in gut microbiota in patients with ischemic stroke are associated with the development of disease. However, there are few studies on the correlation between ischemic stroke with cancer and human microbiome and metabolites Whether the human microbiome and its metabolites are associated with the prognosis of such patients remains to be investigated. Therefore, this study hypothesized that structural changes in the human microbiome and its metabolites in patients with acute ischemic stroke with active cancer were associated with stroke severity and disease recovery Therefore, this topic proposed by collecting active follow-up cancer of acute ischemic stroke patients after admission and oral swabs Excrement and urine and blood samples, and based on the queue, follow-up analysis of the human microbiome dynamic change rule and the prognosis of patients with cancer of the acute ischemic stroke correlation, activity, further explore the secondary prevention of stroke management strategy based on the human microbiome.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1: It meets the diagnostic criteria for acute ischemic stroke
  • 2: Age ≥ 18 years
  • 3: The onset time is less than or equal to 2 weeks
  • 4: Diagnosis of cancer before stroke onset or during hospitalization and active cancer (failure to meet clinical criteria for cure, or discovery of recurrence or metastasis)
  • 5: Sign an informed consent form, provide relevant medical history information and provide biological specimens

排除标准

  • 1: Previous history of disabling stroke (pre-onset mRS ≥2)
  • 2: Primary central nervous system tumor or hematologic system tumor
  • 3: The cancer meets the criteria for clinical cure and has not recurred or metastasized for more than 5 years
  • 4: Antibiotics, prebiotics/probiotics taken within 1 month
  • 5: Patients who cannot have stool specimens within 4 days of admission

结局指标

主要结局

Neurological function score (mRS score)

时间窗: 3 months after onset

Neurological function score (mRS score) ,The minimum score is 0 and the maximum score is 5,The higher the mRS score, the worse the prognosis

Mortality

时间窗: 3 months after onset

Mortality

次要结局

  • Mini-mental State Examination(Seventh day of hospitalization、3 months and 6 months after onset)
  • National Institutes of Health Stroke Scale score(NIHSS score)(The first and seventh days of hospitalization、3 months, 6 months and 12 months after onset)
  • Barthel Index(3 months, 6 months and 12 months after onset)
  • Montreal Cognitive Assessment(Seventh day of hospitalization、3 months and 6 months after onset)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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