Association of PeRiODontal Disease and gUt Microbiome With Coronary artEry Disease (PRODUCE Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Periodontitis
- Sponsor
- Yonsei University
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- The association between periodontal disease and cardiovascular disease
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged from 19 to 80 years who underwent invasive coronary angiography for clinical necessity, with informed consent
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
The association between periodontal disease and cardiovascular disease
Time Frame: 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
Secondary Outcomes
- 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))