Study Results
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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RECRUITING
200 participants
OBSERVATIONAL
2025-11-01
2029-11-01
Brief Summary
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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.
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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Vulnerable Plaque Group
Participants with vulnerable carotid plaques, identified based on ultrasound gray-scale median (GSM) score, photon-counting CT angiography, and MR plaque characterization.
Sample Collection
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.
Stable Plaque Group
Participants with stable carotid plaques, classified by imaging criteria indicating low vulnerability.
Sample Collection
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.
Interventions
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Sample Collection
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Research, Development and Innovation Office, Hungary
UNKNOWN
Semmelweis University Heart and Vascular Center
OTHER
Responsible Party
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Prof. Dr. Sótonyi Péter
MD, DSc, Head of Department of Vascular and Endovascular Surgery
Locations
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Városmajor Heart and Vascular Center, Semmelweis University
Budapest, , Hungary
Countries
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Facility Contacts
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Zsuzsanna Németh, MD, PhD
Role: primary
Márk Matus, MD, PhD
Role: backup
References
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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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form: Consent Form
Document Type: Informed Consent Form: Information Form
Related Links
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Városmajor Biobank - Transplant Biobank
Other Identifiers
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NKFI-Advanced 149634
Identifier Type: -
Identifier Source: org_study_id
NKFI-Advanced 149634
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
BM/33955-1/2023
Identifier Type: OTHER
Identifier Source: secondary_id