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

NCT ID: NCT05560087

Last Updated: 2025-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-12-05

Brief Summary

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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

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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.

Conditions

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Periodontitis Coronary Heart Disease Human Microbiome Dysbiosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Coronary artery disease

No interventions assigned to this group

control

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jong-Won Ha

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

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Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2022-0533

Identifier Type: -

Identifier Source: org_study_id

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