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临床试验/NCT04803838
NCT04803838
进行中(未招募)
不适用

The Gut and Oral Bacteria, Atherosclerosis and Ischemic Stroke Study

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 290 人2018年1月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Ischemic Stroke
发起方
Oslo University Hospital
入组人数
290
试验地点
1
主要终点
Number of participants With MRI-confirmed acute ischemic stroke related to increased Levels of serum microbiota-metabolites as assessed by blood tests.
状态
进行中(未招募)
最后更新
3个月前

概览

简要总结

The main aim of this project is to demonstrate an association between gut and oral microbiota and their metabolites to carotid atherosclerosis and risk of ischemic stroke.

The investigators aim to show that these metabolite levels are diet-dependent (mainly egg yalk and red meat) and associated with specific types of microbiota.

The investigators to assess serum microbiota metabolite levels as a predictor of stroke and plaque progression for patients with carotid atherosclerosis.

详细描述

The Project will include four studies: Study 1: (Comparative cross-sectional study) The main objective in this study is to assess if patients with carotid atherosclerosis have increased serum levels gut microbiota dependent metabolites compared to healthy controls. This study will be done on prospectively collected information already available in our existing database. Approximately 215 patients will be included in this study where collected samples will be analyzed and levels of metabolites quantified. These metabolite levels will be compared to a control group of 70 healthy controls without carotid atherosclerosis (verified by ultrasound), cardiovascular outcome defined as stroke/TIA or vascular death, as well as traditional risk factors for ischemic stroke (diabetes, hypertension, smoking and coronary artery disease). Study 2: (Comparative cross-sectional study) The aim of this study is to asses if microbiota and microbiota metabolite Levels are Associated With certain types of diet, in particular Rich in red meat and egg yalk. In this study, 215 patients with ultrasound verified carotid atherosclerosis with or without symptoms of TIA/stroke will be compared to 70 controls. Dietary intake and food habits will be recorded using the SmartDiet questionnaire developed by 'Lipidklinikken Rikshospitalet'. Feces, saliva and blood will be collected analyzed for microbiota and metabolites. Antroprometrics, blood pressure and pulse will be recorded. In patients undergoing carotid endarterectomy and immunohistochemical analysis will be done. Study 3: (Comparative cross-sectional study) The aim of this study is to evaluate correlation between the microbiota and microbiota metabolite Levels With other inflammatory markers in blood, as well as known risk factors for stroke and inflammation on imaging modalities (ultrasound, 3-T MRI and PET/CT) . In this study, 215 patients with ultrasound verified carotid atherosclerosis with or without symptoms of TIA/stroke will be compared to 70 controls. Patients will undergo investigations with carotid ultrasound, carotid and cerebral MR imaging, blood tests including inflammatory biomarkers. A sub-group of patients will in addition undergo PET/CT imaging of carotid arteries. Study 4: (Follow up study) The aim of this study is to evaluate the ability of microbiota and microbiota metabolites to predict ischemic stroke in patient With carotid stenosis. Patients in study 2 and 3 will be followed up after 2 years with repetition of investigations. Findings with serum levels of microbiota metabolites, traditional risk factors and imaging will be correlated to clinical and radiological ischemic events and plaque progression.

注册库
clinicaltrials.gov
开始日期
2018年1月1日
结束日期
2026年8月1日
最后更新
3个月前
研究类型
Observational
性别
All

研究者

发起方
Oslo University Hospital
责任方
Principal Investigator
主要研究者

Mona Skjelland

Clinical Professor

Oslo University Hospital

入排标准

入选标准

  • \- patients \>18 years with an symptomatic og asymptomatic atherosclerotic carotid stenosis ≥ 50% (NASCET criteria)

排除标准

  • active infection
  • current antibiotic treatment
  • autoimmune or autoinflammatory disease
  • malignancies

结局指标

主要结局

Number of participants With MRI-confirmed acute ischemic stroke related to increased Levels of serum microbiota-metabolites as assessed by blood tests.

时间窗: 2 years

Blood test (microbiota-metabolites e.g. TMAO) at study inclusion, carotid ultrasound (carotid plaque assessment and degree of stenosis) and cerebral MRI (evidence of stroke) at follow up

次要结局

  • Number of participants With increased Levels of microbiota-metabolites related to Diet Rich in red meat and egg yalk as assessed by 'Smart Diet' questionnaire.(At inclusion)
  • Number of participants With increased Levels of microbiota-metabolites related to traditional risk factors for ischemic stroke assessed by questionnaire and Medical journal.(At inclusion)
  • Number of participants With increased Levels of microbiota-metabolites related to signs of plaque instability on imaging studies assessed by carotid ultrasound, carotid and cerebral MRI and for a subgroup: carotid PET/CT.(At inclusion)
  • Number of participants with progression of carotid stenosis related to increased Levels of serum microbiota-metabolites as assessed by blood tests.(2 years)
  • Number of participants With increased Levels of microbiota-metabolites related to specific types of microbiota in feces and saliva as assessed by next generation sequencing and 16S RNA.(At inclusion)

研究点 (1)

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