Mouth bacteria and carotid artery plaque vulnerability

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.