Is Our Microbiome a Predictor of Cardiac Risk?
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- 50 cc blood obtained during angiogram and used for Endothelial Progenitor Cells analysis using antibodies for inflammatory markers. Plasma collection will be done for antibody analysis. Buffy coats will be frozen and stored for future genetic analysis.
研究概览
简要总结
The purpose of this study is to determine a relationship between a person's flora/bacteria in their gut (the intestinal microbiome) and their risk of cardiovascular disease. Investigators will look at inflammatory markers in the blood and also look at the genome of the bacteria in the gut.
详细描述
Investigators will look at inflammatory markers in the blood and also look at the genome of the bacteria in the gut. This research is being done because Investigators believe that there is a connection between the way food is digested by a person's gut bacteria and the development of atherosclerosis (hardening of the arteries) and cardiovascular disease. The ultimate goal of this research is to eventually determine if changes to the gut bacteria can prevent cardiovascular disease or disease progression.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anyone undergoing cardiac catheterization for suspected coronary artery disease over age 18.
排除标准
- •Patients currently on long-term antibiotics who cannot stop them for at least 2 weeks prior to providing a stool sample.
- •Patients on chronic laxatives who cannot stop for at least 2 weeks prior to stool collection.
- •Patients on probiotics and cannot stop for 2 weeks prior to giving a stool sample (yogurt is ok).
- •Patients who are unable to provide a stool sample to Mayo Clinic within 24 hours of collection utilizing Fed Ex overnight mail (i.e. people overseas who are unable to provide a sample before leaving the USA.)
结局指标
主要结局
50 cc blood obtained during angiogram and used for Endothelial Progenitor Cells analysis using antibodies for inflammatory markers. Plasma collection will be done for antibody analysis. Buffy coats will be frozen and stored for future genetic analysis.
时间窗: Blood samples will be obtained during the diagnostic angiogram.
次要结局
- Stool samples will be collected to compare the fecal microbiota of patients with mild, moderate and severe coronary artery disease.(Two weeks after the angiogram)