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临床试验/NCT04795687
NCT04795687Unknown不适用

Association of Metagenomics and Transcriptomics With the Appearance and Evolution of an Ischemic Stroke

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年7月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Risk of stroke and disability after a stroke

研究概览

简要总结

The composition of the intestinal microbiota is associated with the risk of stroke and with post-stroke neurological evolution. At the same time, the genetics and epigenetics of each patient are associated with the composition of the intestinal microbiota. The study of the microbiome in stroke patients will allow finding new therapeutic targets for the treatment of stroke patients.

For the study, samples will be collected from those patients with ischemic stroke who come to the hospital while the study is being carried out, taking into account certain criteria: the patients must be over 18 years of age, have suffered an ischemic stroke (demonstrated by resonance or head CT), not have any additional serious illness or unstable medical condition, and not be included in clinical trials with neuroprotective drugs. On the other hand, the control group will be asymptomatic, and will be made up of people who have not previously suffered a stroke or a cardiovascular event and who do not have diseases that affect the digestive tract.

The main variables of the study are the risk of stroke and disability after a cerebrovascular accident (measured by mRS at 3rd month). Microbiota, genetic and epigenetic variables are also taken into account, such as the presence and levels of bacteria, dysbiosis, genetic polymorphisms and levels of methylation in CpG islands.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Patients with ischemic stroke (demonstrated by resonance or head CT).

排除标准

  • Patients under 18 years of age.
  • Additional serious illness or unstable medical condition.
  • Inclusion in clinical trials with neuroprotective drugs.

结局指标

主要结局

Risk of stroke and disability after a stroke

时间窗: 3 months

Use of the Modified Rankin Scale (mRS), evaluted from 0 to 6 (where higher scores mean worse outcome), to asses disability in patients who have suffered a stroke and comparison over time to check for recovery and degree of continued disability

次要结局

未报告次要终点

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (1)

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