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

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.

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Key information

Conditions

Periodontitis Cardiovascular Diseases Coronary Disease Coronary Heart Disease Dysbiosis Heart Diseases Human Microbiome Mouth Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Stomatognathic Diseases Vascular Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 among periodontitis, gut microbiome and biomarkers

Time frame: within 3 years after enrollment (until the completion of dataset)

The association between periodontal disease and biomarkers by independent t-test
The associations between periodontitis and cognitive function

Time frame: within 3 years after enrollment (until the completion of dataset)

The associtation between periodontal disease and cognitive function by chi-square test

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Sep 29, 2022
Registry last updated: Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed