The Role of Gut Leakage Markers and Microbiota Signature in Coronary Artery Disease.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Lipopolysaccharide binding protein (LBP) in myocardial infarction
研究概览
简要总结
Define a signature of gut microbiota composition and related metabolites in patients with ST-elevation myocardial infarction, non ST-elevation myocardial infarction and chronic coronary disease (CAD).
详细描述
A total of 200 patients, allocated to 50 patients with chronic coronary syndrome, 75 patients with non-ST elevation myocardial infarction and 75 patients with ST- elevation myocardial infarction will be included. Clinical information, blood samples and fecal samples will be collected. Fecal and blood samples will be collected once in patients With chronic disease and in patients with acute coronary syndrome; in the acute phase and after 3 months.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary heart disease verified by coronary angiography
排除标准
- •Current infection requiring intravenous antibiotics
- •Inflammatory bowel disease
- •Renal failure with creatinine > 200µmol/L
- •Hepatic impairment
- •Pregnancy
- •Previous bariatric surgery
- •Colostomy
- •Active malignant disease
结局指标
主要结局
Lipopolysaccharide binding protein (LBP) in myocardial infarction
时间窗: Change from inclusion to 3 months follow-up.
Blood sample. Analyses will be performed with ELISA.
Microbiota alpha diversity in myocardial infarction measured as Chao1 Index
时间窗: At 3 months follow-up.
fecal-sample. 16srRNA (Miseq) will be used for sequencing.
Microbiota alpha diversity in myocardial infarction measured as Chao1 Index.
时间窗: Within 7 days from inclusion.
fecal-sample. 16srRNA (Miseq) will be used for sequencing.
Soluble cluster of difference-14 in myocardial infarction
时间窗: Change from inclusion to 3 months follow-up.
Blood sample. Analyses will be performed with ELISA.
Intestinal fatty acid binding protein-1 in myocardial infarction
时间窗: Change from inclusion to 3 months follow-up.
Blood sample. Analyses will be performed with ELISA.
次要结局
未报告次要终点
研究者
Geir Øystein Andersen
MD, PhD, Senior Cardiologist
Oslo University Hospital