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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Identification of Oral and Carotid Plaque Microbiome Associations
研究概览
简要总结
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 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.
详细描述
Background and Rationale: Cardiovascular diseases are currently the leading cause of death globally, according to the World Health Organization. Recent studies report a 4.2% prevalence of moderate to severe carotid artery stenosis. A growing body of evidence highlights the association between poor oral health and vascular disease. Periodontitis is a highly prevalent condition, affecting approximately 10% of the global population with its severe form (1). Several studies have revealed correlations between the severity of periodontal disease and the presence of pathogenic bacteria in carotid (2) and atherosclerotic plaques (3).
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Stable Plaque Group
Participants with stable carotid plaques, classified by imaging criteria indicating low vulnerability.
干预措施: Sample Collection (Other)
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.
干预措施: Sample Collection (Other)
结局指标
主要结局
Identification of Oral and Carotid Plaque Microbiome Associations
时间窗: At time of carotid endarterectomy
Microbiome composition of oral and carotid plaque samples will be analyzed using next-generation sequencing to identify bacterial taxa correlated with plaque vulnerability. Relative abundance and diversity indices will be compared between participants with vulnerable and stable carotid plaques to determine microbial associations linked to plaque instability.
次要结局
- Differences in Microbiome Composition Between Vulnerable and Stable Carotid Plaques(At time of carotid endarterectomy)
- Identification of Shared Microbial Taxa Across Oral, Anal, Urine, and Carotid Plaque Samples(At time of carotid endarterectomy)
研究者
Prof. Dr. Sótonyi Péter
MD, DSc, Head of Department of Vascular and Endovascular Surgery
Semmelweis University Heart and Vascular Center