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

NCT05560087 | Completed

• 1 other identifier: 4-2022-0533
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Coronary Heart Disease; Human Microbiome; Dysbiosis

Outcome Measures

Primary Outcomes (1)

• The association between periodontal disease and cardiovascular disease

  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

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

Secondary Outcomes (2)

• The associations among periodontitis, gut microbiome and biomarkers

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

• The associations between periodontitis and cognitive function

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

Study Arms (2)

Coronary artery disease

control

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged from 19 to 80 years who underwent invasive coronary angiography for clinical necessity in single tertiary hospital

You may qualify if:

• Patients aged from 19 to 80 years who underwent invasive coronary angiography for clinical necessity, with informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Stool, and Gingival crevicular fluid

MeSH Terms

Conditions

Periodontitis; Coronary Disease; Dysbiosis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jong-Won Ha

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 29, 2022
• Study Start: July 1, 2022
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Locations

KR (1)