Condition: Atherosclerosis Cardiovascular Disease · Atherosclerosis of Artery · Carotid Artery Plaque · Sponsor: Semmelweis University Heart and Vascular Center
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. 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 bacteri…
This description comes directly from the study's public registry record.
Zsuzsanna Németh, MD, PhD · +36-30-261-1559 · zsuzsannamihaly@gmail.com
Mathew J Mitchell, MD Candidate · +36-30-279-1038 · mathew.mitchell@fulbrightmail.org
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| Városmajor Heart and Vascular Center, Semmelweis University | Budapest, Hungary | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07296965