Microbiome, Inflammation and Genetics as a Target for Precision Medicine in AThERosclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Change from baseline in clinical evaluation at 12 months
研究概览
简要总结
Cardiovascular diseases are the main cause of death in industrialized countries. Among them, atherosclerosis has the highest prevalence and constitutes a common pathological pathway responsible for the majority of cases of chronic ischemic heart disease, acute myocardial infarction, heart failure and cerebrovascular disease. Classic studies have confirmed well-established etiopathogenic factors of atherosclerosis based on genetic and immunological components and environmental modifying agents such as diet and exercise. But in addition, recent experimental studies have shown that dysbiosis (alteration of the microbiota) may be an additional factor that participates in the onset and progression of atherosclerosis. The objective of this study is to identify the potential interactions between changes in the microbiota, changes in the immune status, the clinical evolution and the instability and progression of atherosclerosis.
详细描述
The study will prospectively study two groups of patients : 1) patients with acute coronary syndrome and 2) age and sex matched patients with chronic stable documented atherosclerosis.
Immune cell populations and immune-related metabolites will be characterized, the genetic profile of the main known functional variants will be determined, and the oral, gastrointestinal, and blood microbiota will be compared in both groups in a transversal observational design.
In addition, 1-year clinical follow-up will be performed and correlation with the evolution of the microbiota and immune response in a longitudinal design will be conducted.
Besides, an angiographic substudy, for those patients included in the study but that require revascularization of culprit artery according to clinical indication, will be 1 year follow-up and functional assessment and intravascular imaging and the degree of remodelling of the atherosclerotic plaque will be correlated with the evolution of the microbiota and immune response in a longitudinal design.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from baseline in clinical evaluation at 12 months
时间窗: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Cardiac events register including hemostasis and biochemical determinations
Change from baseline in fibrous cap thickness at 12 months
时间窗: Inclusion and 12 months
Angiographic substudy-Change from baseline in the thickness of the fibrous cap (μm) of an atherosclerotic plaque in the nonculprit vessel as measured using optical coherence tomography
次要结局
- Oral microbiota composition changes 16S(Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months)
- Endothelial dysfunction(Inclusion and 12 months)
- Intestinal microbiota composition changes metagenome(Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months)
- Blood microbiota composition changes metagenome(Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months)
- Intestinal microbiota composition changes 16S(Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months)
- Oral microbiota composition changes metagenome(Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months)
- Adaptive immune system status changes(Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months)
- Blood microbiota composition changes 16S(Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months)
- Innate immune system status changes(Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months)
研究者
Javier Bermejo Thomas
MD PhD Cardiology Department HGUGM
Hospital General Universitario Gregorio Marañon