Actively Recruiting

Age: 18Years +
All Genders
ID07296965

The Role of the Oral Microbiome in Carotid Atherosclerosis: Investigating Microbial Influence on Plaque Development and Vulnerability Using Biobank Data

Led by Semmelweis University Heart and Vascular Center · Updated on 2026-04-22

200

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

S

Semmelweis University Heart and Vascular Center

Lead Sponsor

N

National Research, Development and Innovation Office, Hungary

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to explore how bacteria living in the mouth may affect the development and stability of plaques in the carotid arteries, which supply blood to the brain. The study focuses on adults scheduled for carotid endarterectomy and investigates whether certain oral bacteria are related to plaque vulnerability, potentially increasing the risk of stroke. Researchers will compare bacterial patterns between people with vulnerable and stable carotid plaques to better understand this connection. Participants will undergo an oral health examination before surgery to assess gum disease and tooth infections. During carotid endarterectomy, samples will be collected from the mouth, anus, urine, blood, and carotid plaques for microbiome analysis. Preoperative photon-counting computed tomography (CT) and other imaging methods like magnetic resonance (MR) and ultrasound will be used to assess plaque stability and confirm eligibility. All samples and imaging data will be anonymized and stored in a biobank. During the study, participants will provide multiple biological samples and undergo imaging assessments. Researchers will analyze these to identify bacterial species and their relationship to plaque types. The main outcome is to find associations between oral bacteria and carotid plaque vulnerability. There is no experimental treatment involved, and participation does not add significant risk beyond standard care. The study will help develop future risk models for stroke based on microbiome data.

CONDITIONS

Brief Title

Oral Microbiome in Carotid Atherosclerosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed internal carotid artery stenosis on preoperative photon-counting computed tomography (CTA)
  • Adults aged 18 years or older undergoing carotid endarterectomy at Semmelweis University
  • Eligible for surgery based on standard anesthesiologic evaluation
  • Willing and able to provide written informed consent for participation and sample collection
Not Eligible

You will not qualify if you...

  • Active systemic infection or antibiotic treatment within 30 days before surgery
  • Receiving immunosuppressive therapy or having immunodeficiency disorders
  • Unable to undergo MRI due to pacemaker, metallic implants, or severe claustrophobia
  • Pregnancy or breastfeeding
  • Currently undergoing treatment for cancer
  • Prior carotid surgery or stenting on the same side
  • Refusal or inability to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment including photon-counting computed tomography (CTA)

Diagnostic Evaluation

Duration - Up to 1 week before surgery

Participants undergo non-invasive magnetic resonance (MR) and ultrasound imaging to classify carotid plaque vulnerability.

1 to 2 imaging visits (in-person)

Sample Collection

Duration - Day of surgery

Participants undergo preoperative oral health evaluation and collection of oral, anal, urine, blood, and carotid plaque samples during carotid endarterectomy for microbiome analysis.

1 surgical visit with sample collection

Trial Site Locations

Total: 1 location

1

Városmajor Heart and Vascular Center, Semmelweis University

Budapest, Hungary

Actively Recruiting

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Research Team

Z

Zsuzsanna Németh, MD, PhD

M

Mathew J Mitchell, MD Candidate

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Microbiome composition comparison in oral and atherosclerotic plaque from patients with and without periodontitis.

Daichi Isoshima, Keisuke Yamashiro, Kazuyuki Matsunaga...

https://pubmed.ncbi.nlm.nih.gov/32430725

Oral microbiota and atherothrombotic carotid plaque vulnerability in periodontitis patients. A cross-sectional study.

Adrian Brun, Alexandre Nuzzo, Bastien Prouvost...

https://pubmed.ncbi.nlm.nih.gov/33368263