Microbiome composition comparison in oral and atherosclerotic plaque from patients with and without periodontitis.
Daichi Isoshima, Keisuke Yamashiro, Kazuyuki Matsunaga...
https://pubmed.ncbi.nlm.nih.gov/32430725Actively Recruiting
Led by Semmelweis University Heart and Vascular Center · Updated on 2026-04-22
200
Participants Needed
1
Research Sites
104 weeks
Total Duration
S
Semmelweis University Heart and Vascular Center
Lead Sponsor
N
National Research, Development and Innovation Office, Hungary
Collaborating Sponsor
This research aims to explore how bacteria living in the mouth may affect the development and stability of plaques in the carotid arteries, which supply blood to the brain. The study focuses on adults scheduled for carotid endarterectomy and investigates whether certain oral bacteria are related to plaque vulnerability, potentially increasing the risk of stroke. Researchers will compare bacterial patterns between people with vulnerable and stable carotid plaques to better understand this connection. Participants will undergo an oral health examination before surgery to assess gum disease and tooth infections. During carotid endarterectomy, samples will be collected from the mouth, anus, urine, blood, and carotid plaques for microbiome analysis. Preoperative photon-counting computed tomography (CT) and other imaging methods like magnetic resonance (MR) and ultrasound will be used to assess plaque stability and confirm eligibility. All samples and imaging data will be anonymized and stored in a biobank. During the study, participants will provide multiple biological samples and undergo imaging assessments. Researchers will analyze these to identify bacterial species and their relationship to plaque types. The main outcome is to find associations between oral bacteria and carotid plaque vulnerability. There is no experimental treatment involved, and participation does not add significant risk beyond standard care. The study will help develop future risk models for stroke based on microbiome data.
CONDITIONS
Oral Microbiome in Carotid Atherosclerosis
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment including photon-counting computed tomography (CTA)
Duration - Up to 1 week before surgery
Participants undergo non-invasive magnetic resonance (MR) and ultrasound imaging to classify carotid plaque vulnerability.
1 to 2 imaging visits (in-person)
Duration - Day of surgery
Participants undergo preoperative oral health evaluation and collection of oral, anal, urine, blood, and carotid plaque samples during carotid endarterectomy for microbiome analysis.
1 surgical visit with sample collection
Total: 1 location
1
Városmajor Heart and Vascular Center, Semmelweis University
Budapest, Hungary
Actively Recruiting
Z
Zsuzsanna Németh, MD, PhD
M
Mathew J Mitchell, MD Candidate
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Daichi Isoshima, Keisuke Yamashiro, Kazuyuki Matsunaga...
https://pubmed.ncbi.nlm.nih.gov/32430725Adrian Brun, Alexandre Nuzzo, Bastien Prouvost...
https://pubmed.ncbi.nlm.nih.gov/33368263Jo E Frencken, Praveen Sharma, Laura Stenhouse...
https://pubmed.ncbi.nlm.nih.gov/28266116