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Atherosclerosis Cardiovascular DiseaseOMICANCT07296965

Oral Microbiome in Carotid Atherosclerosis

An observational study of Atherosclerosis Cardiovascular Disease and Atherosclerosis of Artery, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this observational study, called OMICA (Oral Microbiome in Carotid Atherosclerosis), is to learn how bacteria living in the mouth may influence the development and stability of plaques in the carotid arteries, which supply blood to the brain. Plaque buildup in these arteries can lead to stroke. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sample Collection
Type of treatment
Pill or oral medicine
How many people
200 participants
Where
1 siteHungary
Study dates
1 Nov 2025to 1 Nov 2029
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants will be recruited from patients undergoing carotid endarterectomy at Semmelweis University, Budapest, Hungary, within the framework of the Semmelweis Carotid Plaque Biobank. Eligible individuals are adults with confirmed internal carotid artery stenosis identified by photon-counting CT angiography. Enrollment is consecutive among surgical candidates who provide informed consent. The study population reflects a tertiary vascular surgery center cohort representing both stable and vulnerable plaque phenotypes, as classified by ultrasound, MR, and CTA imaging.

Who may be able to join

  • Confirmed internal carotid artery (ICA) stenosis on preoperative photon-counting computed tomography (CTA)
  • Adults (≥18 years) 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.

Who cannot join

  • Active systemic infection or current antibiotic therapy within 30 days before surgery.
  • Immunosuppressive therapy or immunodeficiency disorders.
  • Inability to undergo MRI (e.g., pacemaker, metallic implants, severe claustrophobia).
  • Pregnancy or lactation.
  • Malignancy under active treatment.
  • Prior carotid surgery or stenting on the same side.
  • Refusal or inability to provide informed consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zsuzsanna Németh, MD, PhD contact

+36-30-261-1559

zsuzsannamihaly@gmail.com

Mathew J Mitchell, MD Candidate contact

+36-30-279-1038

mathew.mitchell@fulbrightmail.org

Hungary1 site, 1 recruiting
  • Városmajor Heart and Vascular Center, Semmelweis University

    Budapest

    Zsuzsanna Németh, MD, PhD, +36-30-2611559, zsuzsannamihaly@gmail.com

    Márk Matus, MD, PhD, markmatusmd@gmail.com

    Recruiting

Other trials in Hungary

About this study

Official title: The Role of the Oral Microbiome in Carotid Atherosclerosis: Investigating in a Cross-sectional Study the Microbial Influence on Plaque Development and Vulnerability Based on Biobank Data

The goal of this observational study, called OMICA (Oral Microbiome in Carotid Atherosclerosis), is to learn how bacteria living in the mouth may influence the development and stability of plaques in the carotid arteries, which supply blood to the brain. Plaque buildup in these arteries can lead to stroke.

Researchers want to understand whether certain oral bacteria are linked to plaque vulnerability, meaning a higher chance that the plaque will rupture and cause a stroke.

Read more

The study will include a cohort of adults scheduled for carotid endarterectomy at Semmelweis University. Participants will be enrolled in the Semmelweis University Carotid Biobank project.

The main questions the study aims to answer are:

Do people with more severe gum disease or tooth infection have a higher number of bacteria in their carotid plaques, and are those plaques more likely to rupture?

Are the bacteria found in vulnerable plaques different from those in stable plaques?

Are similar bacteria found in the mouth, gut, and plaques, suggesting that bacteria may travel through the body?

What participants will do:

Have their oral health checked before surgery, including an exam of gum disease and tooth infections.

Provide microbiome samples from the mouth, anus, urine, and carotid plaque (taken during surgery).

Have preoperative photon-counting computed tomography (CT) performed to assess plaque stability and study eligibility.

All samples and imaging data will be analyzed to identify bacterial species and their relationship to plaque type.

The study does not involve any experimental treatment or medication. Participation adds no significant medical risk beyond standard care.

Researchers will compare bacterial patterns between people with vulnerable plaques and those with stable plaques to identify microbial signatures linked to carotid plaque instability.

The results may help create future microbiome-based risk models for detecting people at higher risk of stroke or severe atherosclerosis.

Read the detailed description

Background and Rationale: Cardiovascular diseases are currently the leading cause of death globally, according to the World Health Organization. Recent studies report a 4.2% prevalence of moderate to severe carotid artery stenosis. A growing body of evidence highlights the association between poor oral health and vascular disease. Periodontitis is a highly prevalent condition, affecting approximately 10% of the global population with its severe form (1). Several studies have revealed correlations between the severity of periodontal disease and the presence of pathogenic bacteria in carotid (2) and atherosclerotic plaques (3).

Methods:

Population: The cross-sectional study includes a cohort of patients undergoing carotid endarterectomy: roughly half with vulnerable and half with stable carotid plaques. Photon-counting computed tomography (CTA) is part of the preoperative eligibility assessment confirming internal carotid artery stenosis and determining inclusion in the study. Only non-invasive magnetic resonance (MR) and ultrasound imaging will be requested from participants as part of the study protocol for classification of plaque vulnerability. All imaging data will be anonymized in accordance with Semmelweis University data protection protocols.

Intervention (Sample Collection): This study involves preoperative oral health evaluation and the collection of oral, anal, urine, blood, and carotid plaque samples during carotid endarterectomy for microbiome analysis. All samples and corresponding data will be fully anonymized and processed within the Semmelweis University Carotid Plaque Biobank (BM/33955-1/2023).

Comparator: Patients with vulnerable vs. stable carotid plaques, as classified by carotid duplex ultrasound (GSM score) and photon-counting CTA and MR plaque characterization.

Outcome:

  1. Identification of periodontal and endodontic pathogens in the oral microbiome that positively correlate with plaque severity and vulnerability.
  2. Distinct microbiome compositions in carotid plaques of patients with stable versus vulnerable lesions, supporting the role of bacterial colonization in plaque instability.
  3. Detection of microbiome similarities across oral, anal, and vascular samples, suggesting systemic bacterial dissemination that may contribute to carotid stenosis progression.

Expected Value of Results: This project integrates microbiome and imaging data to explore links between oral bacteria and carotid plaque vulnerability. By investigating the interplay between oral microbiota and vascular disease, the study aims to deepen our understanding of plaque pathogenesis and progression. The findings may contribute to developing microbiome-based risk prediction models for plaque vulnerability, supported by advanced imaging data.

Being tested
Sample Collection
Keywords
Oral Microbiome, Carotid Plaque, Plaque vulnerability, Atherosclerosis, Periodontal disease, Biobank study, Microbial colonization
Medical subject headings
Carotid Stenosis, Periodontitis, Carotid Artery Diseases, Atherosclerosis, Periodontal Diseases, Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sample CollectionOther

    Also called Oral-Systemic Microbiome Analysis, Carotid Plaque Microbiome Sampling

    Participants undergo preoperative oral health evaluation and the collection of oral, anal, urine, blood, and carotid plaque samples during carotid endarterectomy for microbiome analysis. All samples are fully anonymized and processed within the Semmelweis University Carotid Plaque Biobank (BM/33955-1/2023). No experimental treatments are administered; all activities occur within the framework of biobank-approved surgical and diagnostic procedures.

Study groups in NCT07296965
Study groupRoleWhat they receive
Vulnerable Plaque GroupParticipants with vulnerable carotid plaques, identified based on ultrasound gray-scale median (GSM) score, photon-counting CT angiography, and MR plaque characterization.
Receives: Other: Sample Collection
Stable Plaque GroupParticipants with stable carotid plaques, classified by imaging criteria indicating low vulnerability.
Receives: Other: Sample Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identification of Oral and Carotid Plaque Microbiome Associations

    Microbiome composition of oral and carotid plaque samples will be analyzed using next-generation sequencing to identify bacterial taxa correlated with plaque vulnerability. Relative abundance and diversity indices will be compared between participants with vulnerable and stable carotid plaques to determine microbial associations linked to plaque instability.

    Measured: At time of carotid endarterectomy

Secondary outcomes (2)
  1. Differences in Microbiome Composition Between Vulnerable and Stable Carotid Plaques

    Microbial diversity, relative abundance, and taxonomic composition of carotid plaque samples will be compared between vulnerable and stable plaques using 16S rRNA gene sequencing and bioinformatic analysis. Results will help identify microbial signatures associated with plaque stability or vulnerability.

    Measured: At time of carotid endarterectomy

  2. Identification of Shared Microbial Taxa Across Oral, Anal, Urine, and Carotid Plaque Samples

    Microbiome overlap among oral, anal, urine, and carotid plaque samples will be analyzed to detect bacterial species present across multiple body sites, indicating possible systemic dissemination pathways linked to atherosclerotic plaque progression.

    Measured: At time of carotid endarterectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2025
  2. Study start1 Nov 2025
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Nov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT07296965
Sponsor's protocol ID
NKFI-Advanced 149634
Other IDs
NKFI-Advanced 149634, BM/33955-1/2023
Acronym
OMICA
Status last verified
Dec 2025
First submitted
24 Nov 2025
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Individual participant data (IPD) will be de-identified and may be shared with qualified researchers upon reasonable request following completion of the study and publication of primary results, pending ethical and institutional approval.

Publications

  • Isoshima D, Yamashiro K, Matsunaga K, Taniguchi M, Matsubara T, Tomida S, Ota S, Sato M, Shimoe Y, Kohriyama T, Arias Z, Omori K, Yamamoto T, Takashiba S. Microbiome composition comparison in oral and atherosclerotic plaque from patients with and without periodontitis. Odontology. 2021 Jan;109(1):239-249. doi: 10.1007/s10266-020-00524-w. Epub 2020 May 19.

    PubMed 32430725
  • Brun A, Nuzzo A, Prouvost B, Diallo D, Hamdan S, Meseguer E, Guidoux C, Lavallee P, Amarenco P, Leseche G, Bouchard P, Michel JB, Range H. Oral microbiota and atherothrombotic carotid plaque vulnerability in periodontitis patients. A cross-sectional study. J Periodontal Res. 2021 Apr;56(2):339-350. doi: 10.1111/jre.12826. Epub 2020 Dec 25.

    PubMed 33368263
  • Frencken JE, Sharma P, Stenhouse L, Green D, Laverty D, Dietrich T. Global epidemiology of dental caries and severe periodontitis - a comprehensive review. J Clin Periodontol. 2017 Mar;44 Suppl 18:S94-S105. doi: 10.1111/jcpe.12677.

    PubMed 28266116

Questions about this trial

What is this clinical trial studying?

An observational study of Atherosclerosis Cardiovascular Disease and Atherosclerosis of Artery, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zsuzsanna Németh, MD, PhD (+36-30-261-1559, zsuzsannamihaly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of Oral and Carotid Plaque Microbiome Associations (time frame: At time of carotid endarterectomy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07296965, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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