Brief Summary

This study is a prospective, multicenter cohort study conducted in western China. The registry study is primarily conducted at the Department of Neurosurgery, Tangdu Hospital, with participation from the Departments of Neurosurgery at Xi'an Medical University Second Affiliated Hospital, Hanzhong Central Hospital, Hanzhong 3201 Hospital, Baoji People's Hospital, and Pucheng County People's Hospital. The study population consists of patients aged 18 to 90 years undergoing carotid endarterectomy. Patients meeting all inclusion criteria and none of the exclusion criteria may be considered for enrollment after demonstrating informed consent to participate in this registry study and agreeing to sign the informed consent form. All patients enrolled in this study underwent a comprehensive standardized assessment by a multidisciplinary team (including neurology, neurosurgery, laboratory medicine, endocrinology, ultrasound, and other practitioners). The assessment included examinations of neurological, neuropsychological, and psychiatric conditions; endocrine disorders; and hematological indicators. Bacterial species identification was performed using 16S rDNA sequencing, with further validation via transmission electron microscopy. Included patients will undergo routine surgical treatment and follow-up visits as recommended by physicians, with corresponding clinical practice data accurately recorded. Data generated during patient clinical visits will be documented, including preoperative assessment, preoperative care, operating room care, anesthesia management, intraoperative procedures, postoperative medical management, postoperative nursing care, and follow-up information. Inclusion Criteria

1.Patients with clinically diagnosed moderate-to-severe carotid artery stenosis;
2.Age 18 years ≤ age ≤ 90 years;
3.Patients undergoing carotid endarterectomy (CEA) treatment;
4.Preoperative modified Rankin Scale (mRS) score for stroke patients: 0-2;
5.Preoperative NIHSS score for stroke patients: 0-20;
6.Glasgow Coma Scale (GCS) score of 8-15 at hospital admission;
7.No fever or evidence of infection at admission;
8.Informed consent obtained from the subject or legal representative;
9.Good compliance with follow-up requirements.
10.Brain tumors (with mass effect);
11.Patient's Glasgow Coma Scale (GCS) score \<8;
12.Refractory hypertension (defined as sustained systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg) unresponsive to medical therapy
13.History of severe infection within the past three months;
14.Severe or acute heart failure;
15.Acute myocardial infarction or severe arrhythmia;
16.Undergone solid organ surgery or biopsy within the past month;
17.Active bleeding or recent bleeding (gastrointestinal, urinary tract, etc.) within the past month;
18.Currently undergoing hemodialysis or peritoneal dialysis; known severe renal impairment (glomerular filtration rate \<220 mmol/L \[2.5 mg/dL\]);
19.Concurrent malignancy, severe cardiopulmonary disease, or other conditions rendering the patient unable to tolerate surgery;
20.Participation in other interventional clinical studies that may affect outcome assessment;
21.Severe hepatic dysfunction;
22.Other conditions deemed by the investigator as unsuitable for study participation or posing significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric, cognitive, or emotional disorders);
23.Current use of immunosuppressive agents or undergoing immunotherapy.
24.Severe chest or abdominal trauma requiring surgical intervention, or severe traumatic brain injury;
25.Infectious diseases such as syphilis, HIV/AIDS, hepatitis, or tuberculosis;
26.Patients concurrently diagnosed with hypertension and diabetes mellitus.
27.Assess bacterial species within carotid plaques to preliminarily identify correlations between bacterial types and different plaque pathologies;
28.Detect plaque bacteria associated with adverse postoperative outcomes (cerebral infarction, carotid restenosis, mortality), identify risk bacteria linked to poor outcomes, and conduct preliminary functional analysis.
29.Analyze clinical data to assess the correlation between postoperative adverse events and bacteria within high-risk plaques, adjusting for confounding factors including age, gender, body mass index, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, creatinine, diabetes, and hypertension to enhance the reliability of research findings.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

200

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jan 2024

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.8 years study duration

Study Start

First participant enrolled

January 1, 2024

Completed

1.3 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2025

Completed

9 days until next milestone

First Posted

Study publicly available on registry

April 20, 2025

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed

5 months until next milestone

Results Posted

Study results publicly available

March 24, 2026

Completed

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

April 11, 2025

Results QC Date

January 29, 2026

Last Update Submit

March 23, 2026

Conditions

Carotid Artery Stenosis Diabetes Cerebral Infarction Bacteria Bacterial Colonization Hypertension Carotid Plaque Intracellular Bacteria Atherosclerosis of Artery Bacteria in Plaques

Keywords

atherosclerosisintracellular bacteriaCarotid plaqueBacteria in plaques

Outcome Measures

Primary Outcomes (1)

Analysis of Bacterial Types in Plaques
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%.
From enrollment to the end of treatment at 90 days.

Study Arms (6)

Department of Neurosurgery, Tangdu Hospital, Air Force Medical University

The Department of Neurosurgery at Tangdu Hospital, Air Force Medical University, serves as the lead institution for this clinical research and the primary contributor to this multicenter clinical trial. It shoulders the full leadership and core management responsibilities spanning from conceptualization and protocol execution to the completion of the final report.