[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615773":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":10,"enrollmentInfo":76,"targetDuration":79,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":88,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Semmelweis University Heart and Vascular Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vulnerable Plaque Group",null,"Participants with vulnerable carotid plaques, identified based on ultrasound gray-scale median (GSM) score, photon-counting CT angiography, and MR plaque characterization.",[13],"Other: Sample Collection",{"label":15,"type":10,"description":16,"interventionNames":17},"Stable Plaque Group","Participants with stable carotid plaques, classified by imaging criteria indicating low vulnerability.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"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\u002F33955-1\u002F2023). No experimental treatments are administered; all activities occur within the framework of biobank-approved surgical and diagnostic procedures.",[15,9],[24,25],"Oral-Systemic Microbiome Analysis","Carotid Plaque Microbiome Sampling",[27],{"name":28,"affiliation":5,"role":29},"Péter Sótonyi, MD, DSc","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"Zsuzsanna Németh, MD, PhD","CONTACT","+36-30-261-1559","zsuzsannamihaly@gmail.com",{"name":37,"role":33,"phone":38,"phoneExt":10,"email":39},"Mathew J Mitchell, MD Candidate","+36-30-279-1038","mathew.mitchell@fulbrightmail.org",[41],{"facility":42,"status":43,"city":44,"state":10,"zip":10,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Városmajor Heart and Vascular Center, Semmelweis University","RECRUITING","Budapest","Hungary","HU",{"type":48,"coordinates":49},"Point",[50,51],19.04045,47.49835,{"lat":51,"lon":50},[54,56],{"name":32,"role":33,"phone":55,"phoneExt":10,"email":35},"+36-30-2611559",{"name":57,"role":33,"phone":10,"phoneExt":10,"email":58},"Márk Matus, MD, PhD","markmatusmd@gmail.com",{"type":29,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Prof. Dr. Sótonyi Péter","MD, DSc, Head of Department of Vascular and Endovascular Surgery",[63],{"name":64,"class":65},"National Research, Development and Innovation Office, Hungary","UNKNOWN","100615773","oral-microbiome-in-carotid-atherosclerosis-100615773",false,"NCT07296965","Oral Microbiome in Carotid Atherosclerosis","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","OMICA","Inclusion Criteria:\n\n* Confirmed internal carotid artery (ICA) stenosis on preoperative photon-counting computed tomography (CTA)\n* Adults (≥18 years) undergoing carotid endarterectomy at Semmelweis University.\n* Eligible for surgery based on standard anesthesiologic evaluation.\n* Willing and able to provide written informed consent for participation and sample collection.\n\nExclusion Criteria:\n\n* Active systemic infection or current antibiotic therapy within 30 days before surgery.\n* Immunosuppressive therapy or immunodeficiency disorders.\n* Inability to undergo MRI (e.g., pacemaker, metallic implants, severe claustrophobia).\n* Pregnancy or lactation.\n* Malignancy under active treatment.\n* Prior carotid surgery or stenting on the same side.\n* Refusal or inability to provide informed consent.","ALL","18 Years",{"count":77,"type":78},200,"ESTIMATED","1 Year","OBSERVATIONAL","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.\n\nResearchers 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.\n\nThe 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.\n\nThe main questions the study aims to answer are:\n\nDo 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?\n\nAre the bacteria found in vulnerable plaques different from those in stable plaques?\n\nAre similar bacteria found in the mouth, gut, and plaques, suggesting that bacteria may travel through the body?\n\nWhat participants will do:\n\nHave their oral health checked before surgery, including an exam of gum disease and tooth infections.\n\nProvide microbiome samples from the mouth, anus, urine, and carotid plaque (taken during surgery).\n\nHave preoperative photon-counting computed tomography (CT) performed to assess plaque stability and study eligibility.\n\nAll samples and imaging data will be analyzed to identify bacterial species and their relationship to plaque type.\n\nThe study does not involve any experimental treatment or medication. Participation adds no significant medical risk beyond standard care.\n\nResearchers will compare bacterial patterns between people with vulnerable plaques and those with stable plaques to identify microbial signatures linked to carotid plaque instability.\n\nThe results may help create future microbiome-based risk models for detecting people at higher risk of stroke or severe atherosclerosis.",[83,84,85,86,87],"Atherosclerosis Cardiovascular Disease","Atherosclerosis of Artery","Carotid Artery Plaque","Periodontitis","Carotid Artery Diseases",[89,90,91,92,93,94,95],"Oral Microbiome","Carotid Plaque","Plaque vulnerability","Atherosclerosis","Periodontal disease","Biobank study","Microbial colonization","2026-04-21",{"date":98,"type":99},"2026-04-22","ACTUAL",{"date":101,"type":99},"2025-11-01",{"date":103,"type":78},"2029-11-01",{"name":5,"class":6},1]