Trial Outcomes & Findings for Bacteria in Atherosclerotic Plaques and Adverse Events (NCT NCT06935279)
NCT ID: NCT06935279
Last Updated: 2026-03-24
Results Overview
This project aims to establish a patient and specimen registry center for patients undergoing carotid endarterectomy. It involves testing and analyzing plaques from patients who have undergone carotid endarterectomy over a specific period, conducting follow-ups, monitoring blood laboratory indicators, performing data cleaning, analyzing bacterial types within plaques, and identifying bacteria in plaques associated with different disease types to derive corresponding expected conclusions.The relative abundance of bacteria is expressed as a percentage. The higher the percentage of bacteria associated with poor prognosis, the worse the prognosis of the patient is expected to be.Relative abundance is defined as the percentage of sequences of a particular operational taxonomic unit (OTU) in the total effective sequences of the sample, calculated by the formula: Relative abundance (%) = (Number of sequences of a certain OTU / Total effective sequences of the sample) × 100%.
COMPLETED
200 participants
From enrollment to the end of treatment at 90 days.
2026-03-24
Participant Flow
This study is a prospective, multicenter, observational cohort study conducted in western China. It is primarily led by the Department of Neurosurgery at Tangdu Hospital, with participation from five additional hospitals across different regions of Northwest China. Between January 2024 and July 2025, patients meeting all inclusion criteria and none of the exclusion criteria may be considered for enrollment in this study.
A total of 353 research candidates were enrolled in this study. Among them, 98 individuals were excluded due to ineligibility, and 55 declined participation. Ultimately, 200 participants who met the inclusion criteria were enrolled. All enrolled subjects had complete follow-up records.
Participant milestones
| Measure |
PPG Group
Patients in this group who experienced death, carotid restenosis, or stroke within 3 months of carotid endarterectomy during follow-up were classified as the Poor Prognosis Group (PPG group).
|
GPG Group
Patients in this group experienced no serious complications-such as death, carotid restenosis, or stroke-during the three-month follow-up period after carotid endarterectomy. This cohort is classified as the Good Prognosis Group (GPG).
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
180
|
|
Overall Study
COMPLETED
|
20
|
180
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bacteria in Atherosclerotic Plaques and Adverse Events
Baseline characteristics by cohort
| Measure |
PPG Group
n=20 Participants
Based on the surgical prognosis of the patients, we classified those who had an adverse outcome as the Poor Prognosis Group (PPG).
|
GPG Group
n=180 Participants
Based on the surgical prognosis of the patients, we classified those who had a favorable outcome as the Good Prognosis Group (GPG).
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.25 years
STANDARD_DEVIATION 9.24 • n=138 Participants
|
64.68 years
STANDARD_DEVIATION 8.44 • n=62 Participants
|
63.7 years
STANDARD_DEVIATION 8.89 • n=123 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=138 Participants
|
31 Participants
n=62 Participants
|
36 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=138 Participants
|
149 Participants
n=62 Participants
|
164 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=138 Participants
|
160 Participants
n=62 Participants
|
170 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=138 Participants
|
20 Participants
n=62 Participants
|
30 Participants
n=123 Participants
|
|
Number of Participants with Postoperative adverse events
|
20 participants
n=138 Participants
|
0 participants
n=62 Participants
|
20 participants
n=123 Participants
|
PRIMARY outcome
Timeframe: From enrollment to the end of treatment at 90 days.This project aims to establish a patient and specimen registry center for patients undergoing carotid endarterectomy. It involves testing and analyzing plaques from patients who have undergone carotid endarterectomy over a specific period, conducting follow-ups, monitoring blood laboratory indicators, performing data cleaning, analyzing bacterial types within plaques, and identifying bacteria in plaques associated with different disease types to derive corresponding expected conclusions.The relative abundance of bacteria is expressed as a percentage. The higher the percentage of bacteria associated with poor prognosis, the worse the prognosis of the patient is expected to be.Relative abundance is defined as the percentage of sequences of a particular operational taxonomic unit (OTU) in the total effective sequences of the sample, calculated by the formula: Relative abundance (%) = (Number of sequences of a certain OTU / Total effective sequences of the sample) × 100%.
Outcome measures
| Measure |
PPG Group
n=20 Participants
Based on the surgical prognosis of the patients, we classified those who had an adverse outcome as the Poor Prognosis Group (PPG).
|
GPG Group
n=180 Participants
Based on the surgical prognosis of the patients, we classified those who had a favorable outcome as the Good Prognosis Group (GPG).
|
|---|---|---|
|
Analysis of Bacterial Types in Plaques
|
2.2 percentage
Standard Deviation 8.05
|
0.58 percentage
Standard Deviation 3.21
|
Adverse Events
PPG Group
GPG Group
Serious adverse events
| Measure |
PPG Group
n=20 participants at risk
Patients in this group who experienced death, carotid restenosis, or stroke within 3 months of carotid endarterectomy during follow-up were classified as the Poor Prognosis Group (PPG group).
|
GPG Group
n=180 participants at risk
Patients in this group experienced no serious complications-such as death, carotid restenosis, or stroke-during the three-month follow-up period after carotid endarterectomy. This cohort is classified as the Good Prognosis Group (GPG).
|
|---|---|---|
|
Vascular disorders
cerebral infarction
|
80.0%
16/20 • From the conclusion of surgery to the end of follow-up, up to 90 days
The occurrence of new-onset cerebral infarction, recurrent vascular stenosis, or death following surgery constitutes an adverse event in this study.
|
0.00%
0/180 • From the conclusion of surgery to the end of follow-up, up to 90 days
The occurrence of new-onset cerebral infarction, recurrent vascular stenosis, or death following surgery constitutes an adverse event in this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Liu Bei, Director of the Ischemic Cerebrovascular Disease Center at Tangdu Hospital
Tangdu Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place