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

Sponsor

Yonsei University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05560087

Collaborator

(none)

580

Enrollment

Location

Anticipated Duration (Months)

21.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis Coronary Heart Disease Human Microbiome Dysbiosis

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 Design

Study Type:

Observational

Anticipated Enrollment :

580 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Coronary artery disease
control

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

Principal Investigator: Jong-Won Ha, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT05560087

Other Study ID Numbers:

4-2022-0533

First Posted:

Sep 29, 2022

Last Update Posted:

Sep 29, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Periodontitis

Periodontal Diseases

Coronary Artery Disease

Study Results

No Results Posted as of Sep 29, 2022