Mouth bacteria and carotid artery plaque vulnerability
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
This project will see if mouth bacteria are linked to vulnerable carotid plaques in adults having carotid endarterectomy at Semmelweis University.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Semmelweis University Heart and Vascular Center Academic / other |
| Locations | 1 site (Budapest) |
| Trial ID | NCT07296965 on ClinicalTrials.gov |
What this trial studies
OMICA is an observational cross-sectional project enrolling adults undergoing carotid endarterectomy at Semmelweis University's Városmajor Heart and Vascular Center and participating in the Carotid Biobank. Preoperative photon-counting CTA confirms internal carotid stenosis, while non-invasive MRI and ultrasound are used to classify plaques as vulnerable or stable; all imaging is anonymized. Investigators collect oral health information and multiple biological samples — oral, anal, urine, blood, and excised carotid plaque tissue during surgery — for microbiome sequencing. The analysis compares bacterial communities between vulnerable and stable plaques and between plaque and oral sites to identify taxa associated with plaque vulnerability.
Who should consider this trial
Good fit: Adults (≥18) scheduled for carotid endarterectomy at Semmelweis University with confirmed internal carotid artery stenosis who can provide informed consent and are eligible for surgery.
Not a fit: People without carotid stenosis, those not undergoing endarterectomy, or those excluded by recent antibiotics, active infections, immunosuppression, pregnancy, prior ipsilateral carotid surgery, or MRI incompatibility are unlikely to benefit.
Why it matters
Potential benefit: If successful, the findings could enable new biomarkers or prevention strategies linking oral health to stroke risk and help clinicians better identify patients at higher risk of plaque rupture.
How similar studies have performed: Previous observational studies have reported associations between periodontal pathogens and atherosclerotic plaques, but direct evidence linking oral bacteria to plaque rupture remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Budapest
- Városmajor Heart and Vascular Center, Semmelweis University — Budapest, Hungary (Recruiting)
Study contacts
- Principal investigator: Péter Sótonyi, MD, DSc — Semmelweis University Heart and Vascular Center
- Study coordinator: Zsuzsanna Németh, MD, PhD
- Email: zsuzsannamihaly@gmail.com
- Phone: +36-30-261-1559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.