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临床试验/NCT02375893
NCT02375893已完成不适用

The Official Title is in French: Microbiote, Acides Biliaires et Athérome Coronaire (MABAC)

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Gut microbiota composition in coronary patients versus healthy subject

研究概览

简要总结

The purpose of this study is to describe the composition of bile acids and the gut microbiota comparing two populations: patients with coronary atheroma and the healthy subjects.

Our hypothesis is based on the demonstration of the anti atherogenic and anti inflammatory effect of certain bile acids, and the role of the gut microbiota in the metabolic regulation.

详细描述

Atherosclerosis is the main cause of cardiovascular diseases which remain the first cause of death worldwide. The prevention of risk factors can reduce the development of cardiovascular diseases. The final goal of our study is to find new protective or new risk factors that can be modulated to reduce the incidence of cardiovascular events.

Gut microbiota and its main metabolite, the bile acids, are implicated in the metabolic regulation. Some bile acids, especially the secondary bile acids, transformed from the primary bile acids by the bacteria of the gut microbiota, are now demonstrated in murine experimental atherosclerosis models, to be anti inflammatory and anti atherogenic molecules.

We want to compare the pool of bile acids and the composition of gut microbiota between the coronary patients and the healthy subjects to identify the potential protective or deleterious bacteria / bile acids.

All patients admitted for a scheduled coronary angiogram will be included, then divided into two groups: coronary or healthy, based on the presence or the absence of atheroma during the coronary angiogram.

Feces and blood samples, and clinical and biological data, will be collected during the patient's hospitalisation. No additional exam will be performed. The blood sample will be collected during the coronary angiogram or during a routine blood test.

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 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - All patients admitted for a coronary angiogram

排除标准

  • Statins, hypolipemic drugs, corticoids, anti HIV drugs
  • Antibiotics adminisitration in the last 3 months
  • Past of cholecystectomy
  • Hepatic disorders
  • Acute coronary syndrome
  • No agreement, Insufficiency in comprehension
  • Non fasting for at least 8 hours

结局指标

主要结局

Gut microbiota composition in coronary patients versus healthy subject

时间窗: 8 months

Observational only

次要结局

  • Bile acids composition in coronary patients versus healthy subjects, in feces and blood samples(8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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