Association of PeRiODontal Disease and gUt Microbiome With Coronary artEry Disease (PRODUCE Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- The association between periodontal disease and cardiovascular disease
研究概览
简要总结
The purpose of this study is to explore the relationship between periodontal disease and coronary artery disease through changes in the gut microbiome. In addition, the investigators aim to find possible periodontal pathogens that have association with cardiovascular disease.
详细描述
The previous studies have reported the associations among cardiovascular disease, periodontitis, and gut microbiome dysbiosis. However, there is a lack of evidences about the axis of association from oral-gut-cardiovascular disease. The investigators hypothesized that periodontal disease might induce dysbiosis of gut microbiome and dysbiosis might have a role in cardiovascular disease (as called "oro-gut-vascular axis"). The investigators aim to prove this hypothesis through this case-control, cross-sectional study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 19 to 80 years who underwent invasive coronary angiography for clinical necessity, with informed consent
排除标准
- •Patients with prosthetic valve
- •pregnancy
- •active malignancy
- •active autoimmune disease
- •active inflammatory bowel disease
- •chronic kidney disease (eGFR<30, or on dialysis)
- •Active liver disease or liver cirrhosis
- •consistent use of probiotics
- •prior gastrointestinal surgery within 1 year
结局指标
主要结局
The association between periodontal disease and cardiovascular disease
时间窗: within 3 years after enrollment (until the completion of dataset)
The association between periodontal disease and cardiovascular disease by chi-square test The difference of relative abundance in gut microbiome by PERMANOVA test Safety Issue: No
次要结局
- The associations between periodontitis and cognitive function(within 3 years after enrollment (until the completion of dataset))
- The associations among periodontitis, gut microbiome and biomarkers(within 3 years after enrollment (until the completion of dataset))