Association of PeRiODontal Disease and gUt Microbiome With Coronary artEry Disease (PRODUCE Study)

Completed

• Conditions: Coronary Heart Disease; Periodontitis; Dysbiosis; Human Microbiome

• Registration Number: NCT05560087
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-09-29
• Status Verified: 2024-12
• Primary Completion: 2024-12-05
• Study Completion: 2024-12-05
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2025-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The association between periodontal disease and cardiovascular disease	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 Outcome Measures

Name	Time	Method
The associations between periodontitis and cognitive function	within 3 years after enrollment (until the completion of dataset)	The associtation between periodontal disease and cognitive function by chi-square test
The associations among periodontitis, gut microbiome and biomarkers	within 3 years after enrollment (until the completion of dataset)	The association between periodontal disease and biomarkers by independent t-test

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of